Open Cancer Clinical Trials
The following is a listing of studies that are currently open to recruitment at the Dan L. Duncan Cancer Center. Please select the disease group you are interested in.
Breast (available on the BCM Clinical Studies site)
Bladder
Colon and Rectal
Head and Neck
Hodgkin Lymphoma
Kidney (Renal)
Leukemia
Lung
Medulloblastoma
Metastatic Disease
Myeloma
Myeloproliferative Disorder & Myelodysplastic Syndrome
Nasopharyngeal Carcinoma
Neuroblastoma
Non-Hodgkin Lymphoma
Ovarian
Pancreas
Pediatric (available on the Texas Children's web site)
Prostate
Sarcoma
Transplant Studies for Hematological Malignancies
Bladder Cancer
Second/Third Line Treatment for Metastatic Bladder Cancer
Phase II Pilot Study with Correlative Markers of Tamoxifen for Progressive Transitional Cell Carcinoma following Previous Chemotherapy (H-16848): The main purpose of this study is to evaluate the usefulness of daily oral tamoxifen in patients with metastatic bladder cancer, by measuring if the cancer shrinks or remains the same size over 4 months. Patients must have metastatic bladder cancer, and must have received 1-2 prior systemic therapy regimens (chemotherapy or biological therapy or both) but including at least one chemotherapy regimen.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00710970
Contact: Joy Banerjee, 713-798-4479, banerjee@bcm.edu
Maintenance Therapy for Advanced Urothelial Carcinoma
Randomized Blinded Phase II Trial of Maintenance SUO11248 versus Placebo Post Chemotherapy for Patients with Advanced Urothelial Carcinoma (H-22935): The primary purpose of this randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 versus placebo following primary chemotherapy. Patients will have an equal chance of being assigned to receive the study drug or the placebo. Patients must have received 4-6 cycles of standard first line chemotherapy, and must have achieved stable disease, partial response or complete response
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00393796
Contact: Seth Lerner, 713-798-6841
Neoadjuvant Dasatinib and Radical Cystectomy for Transitional Cell Carcinoma of the Bladder
A Pilot Study of Neoadjuvant Dasatinib Followed by Radical Cystectomy for Transitional Cell Carcinoma of the Bladder (H-22995)
This pilot study is designed to determine feasibility and safety of treatment with dasatinib administered orally once daily for 4 weeks duration prior to radical cystectomy for urothelial carcinoma of the bladder. Patients must have invasive TCC of the bladder, and be ineligible for and/or unwilling to receive standard chemotherapy with cisplatin prior to surgery.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00706641
Contact: Seth Lerner, 713-798-6841
OCT Imaging to Stage Bladder Tumors
Optical Coherence Tomography as an Adjunct to White Light Cystoscopy for Intravesical Real Time Imaging and Staging of Bladder Cancer (H-21830): The Niris™ OCT Imaging System is a device used in the operating room together with cystoscopy in order to be able to see the condition of the bladder wall. The primary objective of this study is to assess the accuracy and predictive value of OCT for determining tumor stage, as correlated by histopathology.
The procedure is performed at the same time as a routine cystoscopy is conducted. Patients must have bladder cancer that is amenable to complete resection (stage Ta or T1) and not requiring a cystectomy.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00831558
Contact: Joy Banerjee, 713-798-4479, banerjee@bcm.edu
Adjuvant Chemotherapy for Newly Diagnosed or Recurrent Bladder Cancer
S0337: A Phase III Blinded Study of Immediate Post-Turbt Instillation of Gemcitabine Versus Saline in Patients With Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer (H-21652): The purpose of this study is to determine how well gemcitabine works when given directly into the bladder (as compared to placebo) after surgery. All patients undergo transurethral resection of the bladder tumor. Within 3 hours, patients receive intravesical therapy of intravesical gemcitabine (Arm 1) or intravesical placebo (Arm 2). Patients are followed for 2 years for disease recurrence.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00445601
Contact: Seth Lerner, 713-798-6841
Chemotherapy for Recurrent Bladder Cancer That Has Not Responded to BCG
S0353: Phase II Study of Intravesical Gemcitabine in Patients with Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG (H-20821): The purpose of this study is to find out if gemcitabine is effective against early stage bladder cancer when given directly into the bladder (intravesically). The study involves weekly instillations of gemcitabine into the bladder for 6 weeks, and then, if the cancer does not come back, instillations every 4 weeks for a total of 10 more instillations (10 cycles).
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00234039
Contact: Seth Lerner, 713-798-6841
Genetic Susceptibility to Bladder Cancer
Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach (H-8577)
This clinical research study will identify biologic and lifestyle factors including tobacco use which increase a person's risk of developing specific cancer. Participation will involve a personal interview which will take approximately 1 hour. During this personal interview, detailed information about demographics (the characteristics of human populations such as age, sex and race), medical history, tobacco and alcohol exposure, use of hair dyes, dietary intake, occupational exposure, and family history will be collected. Blood will be taken one time only. Both healthy patients and patients with bladder cancer are eligible to participate.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00848289
Contact: Susan Kingston, 713-798-8514, slk@bcm.edu
Screening for Bladder Cancer (H-20395)
The purpose of this study is to screen men at risk for developing bladder cancer, to find out if there is blood in their urine and if blood does appear in the urine, to compare the results of three tests made to detect cancer cells in urine. Participants will test their urine for the presence of blood every day for two 10-day testing periods.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00848627
Contact: Susan Kingston, 713-798-8514, slk@bcm.edu
Quality of Life and Symptom Management in Patients with Bladder Cancer
Qualitative Study of Patients with Non-Invasive Bladder Cancer (H-21570)
Patients undergo a 10-minute screening in person or by phone to obtain demographic data and medical information (e.g., bladder cancer diagnosis and treatment history). Additional information is obtained from the clinical databases at the Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. Patients who are eligible for the study are added to a waiting list for 1 of 4 focus groups based on disease status (high-risk or low-risk non-invasive bladder cancer) and gender. Patients participate in a 1.5- to 2-hour focus group discussion about the impact of bladder cancer on their quality of life and relationships. Patients receive information about community and internet-based resources at the end of each group session.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00772018
Contact: David Latini, 877-794-7852, CancerOutComes@bcm.edu
Colon and Rectal Cancer
Adjuvant Chemotherapy for Stage 3 Colon Cancer (H-19203)
N0147: A Randomized Phase III Trial of Oxaliplatin plus 5-FU/Leucovorin with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer
This study is designed to compare standard chemotherapy (FOLFOX) to FOLFOX + Cetuximab in patients with resected stage III colon cancer. A sample of the tumor will be tested for KRAS status. Patients with wild-type KRAS will be assigned to FOLFOX or FOLFOX + Cetuximab; patients with mutated KRAS will be assigned to an event monitoring arm (adjuvant treatment is determined by the treating physician). Potential patients are those with resected stage III colon cancer, with no distant metastases and no residual disease. Patients must be randomized within 56 days of surgery. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00079274
First-Line Treatment for Stage 4 Colon or Rectal Cancer (H-19909)
C80405: A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum
This study is for patients with metastatic colorectal cancer, and it will compare three treatments: (A) chemo (FOLFOX or FOLFIRI) + Bevacizumab; (b) chemo + cetuximab; (c) chemo + bevacizumab + cetuximab. To be eligible to participate, patient’s tumor sample must have wild-type KRAS (testing on tumor samples will be paid for by CALGB prior to registration to the trial). Patients must not have received prior systemic treatment for advanced or metastatic colorectal cancer.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00265850
TEMPORARILY CLOSED TO ACCRUAL
Adjuvant Chemotherapy for High-Risk Stage 2 Colon Cancer (H-20158)
E5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
This purpose of this study is to test the possible benefit of adjuvant chemotherapy for patients with stage II colon cancer at high risk of recurrence. Patients who are determined to be at high risk based on molecular testing of tumor tissue will be assigned to chemotherapy alone (FOLFOX) or chemotherapy + bevacizumab. Patients who are determined to be at low risk will be assigned to an observation arm.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00217737
Head and Neck Cancer
Second-Line Treatment for Head and Neck Cancer (H-17107)
OX-04-033: Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
This study is for patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN) that is incurable by local therapy. Treatment is open-label with oxaliplatin and docetaxel. To be eligible patients must have measurable disease by RECIST criteria. Patients must not have received prior chemotherapy after SCCHN is deemed incurable by local therapy. Prior adjuvant or neo-adjuvant chemotherapy is allowed.
NOTE: Open locally at MEDVAMC only. Contact Monique Detiege at 713-791-1414, ext 4667.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00557206
Photo-Thermal Ablation for Recurrent or Refractory Head and Neck Cancer (H-23216)
NBI-07-001: A Pilot Study of AuroLase Therapy in Patients with Refractory and/or Recurrent Tumors of the Head and Neck
The purpose of this study is to examine the safety profile of AuroLase Therapy. Treatment includes an intravenous infusion of AuroShell particles and photo-thermal ablation by an interstitial fiber optic probe inserted near and/or inside the tumor. Patients must have measurable disease with one or more unresectable, refractory and/or recurrent tumor of the head and neck. Tumors must be accessible to examination and to biopsy. Tumors must not be within 1 cm of any critical structure to which thermal damage would result in undue risk to the patient.
NOTE: Open locally at MEDVAMC only. Contact Monique Detiege at 713-791-1414, ext 4667.
Hodgkin Lymphoma
H-11892: A Current Practice Study Of Rituxan In Patients Receiving BEAM Chemotherapy And Autologous Blood Stem Cell Transplantation For High Risk Lymphoma And Hodgkin's Disease: This study uses a monoclonal antibody and high dose chemotherapy combined with autologous stem cell transplantation.
H-9936: Administration Of LMP Specific Cytotoxic T-Lymphocytes To Patients With Relapsed EBV-Positive Hodgkin Disease: This study uses autologous EBV specific T-Lymphocytes targeting the EBV proteins LMP1 and LMP2 to treat lymphoma. http://www.clinicaltrials.gov/ct2/show/NCT00671164
H-8713: Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients with Hematologic Malignancy, Using Haploidentical Family Donors and Sub-Myeloablative Conditioning with Campath 1H: This study uses a monoclonal antibody, low dose chemotherapy and radiation combined with haploidentical allogeneic stem cell transplantation to treat patients with hematologic malignancies who have already received a stem cell transplant or who also have other complications such as kidney, liver, or heart disease.
http://www.clinicaltrials.gov/ct2/show/NCT00675571
H-19275: Administration of LMP1- AND LMP2-specific Cytotoxic T-Lymphocytes following CD45 Antibody to Patients with Relapsed EBV-Positive Hodgkin’s or non-Hodgkin’s Lymphoma: This study uses a combination of monoclonal antibodies and autologous EBV specific T-Lymphocytes to treat lymphoma.
http://www.clinicaltrials.gov/ct2/show/NCT00608478
Kidney Cancer (Renal)
Adjuvant Chemotherapy for Resected Renal Cell Carcinoma (H-20892)
E2805: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
This study is for patients who have had (or will have) a complete resection of renal cell carcinoma. Patients may be registered to the study pre- or post-surgery. Pre-op patients must have primary-intact renal cell cancer with tumor larger than 4 cm and be eligible for nephrectomy with curative intent (full surgical resection, either radical or partial nephrectomy). Patients registered post-op must have undergone a full surgical resection (racial or partial nephrectomy). The study will compare three treatment regimens: (A) sunitinib + placebo-for-sorafenib; (B) sorafenib + placebo-for-sunitinib; (c) placebo-for-sorafenib + placebo-for-sunitinib. Patients must start treatment 4-12 weeks after surgery. Tumor tissue must be available for central pathology review.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00326898
Chemotherapy for Metastatic Renal Cell Carcinoma (H-23915)
E2804: A Randomized Phase II Study of VEGF, RAF kinase and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma: E2804 is for patients with clear cell renal cell carcinoma, with metastatic disease not curable by chemoradiation or surgery. Patients must have had a prior nephrectomy (unless the primary tumor is < 5 cm, or > 30% of liver involved, or > 5 bone metastases). Patients will be randomized to one of four arms: (A) Bevacizumab alone; (B) Temsirolimus + Bevacizumab; (C) Sorafenib + Bevacizumab; (D) Temsirolimus + Sorafenib.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00378703
Genetic Susceptibility to Renal Cell Carcinoma (H-17150)
The goal of this research study is to identify biologic and lifestyle factors that increase a person's risk of developing specific cancers and compare them to healthy people and people with kidney cancer. Patients will be asked questions about their age, race, recent and prior tobacco use, other lifestyle habits, occupational history and family history of cancer. Blood will be taken one time only. Both healthy patients and patients with renal cell carcinoma are eligible.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00854022
Contact: Carmen Bedford, 713-798-2179, bedford@bcm.edu
RAD001 (Everolimus) for Advanced Renal Cell Carcinoma (RCC) Before Kidney Removal
Neoadjuvant RAD001 (Everolimus) for Advanced RCC Before Cytoreductive Nephrectomy, With Correlative Tumor Studies (Protocol #: 06-08-20-01) (H-23409): The purpose of this trial is to discover if RAD001 (Everolimus) is safe and effective in people who have advanced kidney cancer (renal cell carcinoma, RCC). Everolimus is administered for 3-5 weeks before cytoreductive nephrectomy, and then everolimus is resumed and continued until tumor progression or intolerable toxicities. Patients must have advanced (metastatic) RCC, with the histology of clear cell, papillary, or chromophobe. Patients must be a surgical candidate for cytoreductive nephrectomy.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00831480
Contact: Susan Kingston, 713-798-8514, slk@bcm.edu
OPENING SOON
Leukemia
Second-Line Treatment for Chronic Myelogenous Leukemia (H-24047)
A Multi-Center, Open-Label, Exploratory Study of Bcr-Abl Kinetics in Adult Patients on Nilotinib with Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a Suboptimal Molecular Response to Imatinib: This exploratory study will evaluate the change in molecular response in CML - chronic phase patients who have a complete cytogenetic response (CCyR) but a suboptimal molecular response to imatinib. Patients must have a diagnosis of CML-CP (chronic phase) and have a CCyR, with an increase in Bcr-Abl levels (if < 6 years imatinib treatment) or Bcr-Abl not reduced to < 0.1% (if 1-6 years of imatinib treatment). All enrolled patients receive nilotinib until disease progression (measured by Bcr-Abl levels).
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00644878
H-8701: CD34-selection for ex vivo T-cell Depletion of Mobilized Peripheral Blood Stem Cells for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Receiving Intensive Conditioning: This study uses a monoclonal antibody and high dose chemotherapy and radiotherapy combined with haploidentical allogeneic stem cell transplantation to treat pediatric patients with hematologic malignancies.
Optional: Participants in this study may participate in the following protocol, H-9033.
http://www.clinicaltrials.gov/ct2/show/NCT00368355
H-8713: Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients with Hematologic Malignancy, Using Haploidentical Family Donors and Sub-Myeloablative Conditioning with Campath 1H: This study uses a monoclonal antibody, low dose chemotherapy and radiation combined with haploidentical allogeneic stem cell transplantation to treat patients with hematologic malignancies who have already received a stem cell transplant or who also have other complications such as kidney, liver, or heart disease.
http://www.clinicaltrials.gov/ct2/show/NCT00058825
H-17656: Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) with Human IL-2 Gene Modified and Human CD40 Ligand-Expressing Autologous Tumor Cells after Depletion of Regulatory T Cells: This study uses a combination of monoclonal antibodies and autologous gene modified tumor cells (also referred to as a vaccine) which release IL-2 and CD40L to treat patients with CLL.
H-19747: Prolonged Immunization with Autologous CD40 Ligand and IL-2-expressing Tumor Cells for Treatment of B-Chronic Lymphocytic Leukemia (B-CLL): This study uses autologous gene modified tumor cells (also referred to as a vaccine) which release IL-2 and CD40L to treat patients with CLL given over a longer period of time than other studies listed above.
http://www.clinicaltrials.gov/ct2/show/NCT00602121
H23637: Multi-Virus-Specific Cytotoxic T Lymphocytes (CTLs) Expressing CD19 Chimeric Receptors for Prophylaxis of Therapy of Relapse of Acute Lymphoblastic Leukemia Post Hemopoietic Stem Cell Transplantation (MULTIPRAT): This study evaluates T cell specific for three viruses EBV, adenovirus and CMV that have been genetically engineered to recognize a protein called CD19 present on lymphoblastic leukemia cells in patients with early relapse of ALL post transplant.
http://www.clinicaltrials.gov/ct2/show/NCT00840853
Lung Cancer
Second-Line Treatment for Non-Small Cell Lung Cancer (H-23373)
CP02-0452: Randomized Phase III Study of Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer After Platinum-Based Therapy: The purpose of the study is to compare the progression-free survival of pemetrexed + cetuximab to pemetrexed alone in previously treated patients with recurrent or progressive non-small cell lung cancer. Patients must have metastatic, unresectable or locally-advanced NSCLC with measurable disease. Patients must have disease progression during or following one prior platinum-based chemotherapy for advanced disease. (One additional prior regimen is allowed for neoadjuvant, adjuvant or neoadjuvant + adjuvant therapy.) Tumor tissue must be available for EGFR testing at a central lab. Physician will choose the chemotherapy (docetaxel or pemetrexed), then patients will be randomized to one of two arms: (A) Chemo + cetuximab; (B) Chemo alone.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00095199
H 24486 Administration of HER2 Chimeric Receptor and TGFB Dominant Negative Receptor (DNR) Expressing EBV Specific Lymphocytes for Subjects with Advanced HER2 Positive Lung Malignancy: This study evaluates T cells genetically modified to recognize a protein expressed on some lung cancer cells and to be resistant to TGFB.
http://www.clinicaltrials.gov/ct2/show/NCT00889954
Second-Line Treatment for Small Cell Lung Cancer (H-25268)
S0802: A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept) in Patients with Platinum Treated Estensive Stage Small Cell Lung Cancer: The primary objective of the study is to evaluate the efficacy of topotecan hydrochloride with vs without aflibercept, in terms of progression-free survival at 3 months, in patients with extensive stage small cell lung cancer. Patients must have progressive or recurrent disease following one (and only one) standard first-line platinum-containing regimen. Patients are randomized to topotecan alone or topotecan plus aflibercept. Treatment repeats every 21 days until disease progression or unacceptable toxicity.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00828139
Medulloblastoma
H-17089: Treatment of Patients with Newly Diagnosed Medulloblastoma, Supratenterorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor (SJMB03): This study uses high dose chemotherapy and radiation combined with autologous stem cell transplantation to treat patients with medulloblastoma (and related diseases). The study will also be looking at genetic markers to look at how those markers correlate with treatment outcomes.
Metastatic Disease
Therapy for Metastatic or Refractory Head & Neck, Liver, or Prostate Cancer
Open-Label Study of Therapy with Recombinant Human Lactoferrin (rHLF) in Patients with Metastatic or Refractory Cancer (H-16782): The purpose of this Phase II study is to determine whether treatment with oral talactoferrin will reduce tumor growth and metastasis in cancer patients for whom no effective treatment is available. Patients must have progressive, advanced head & neck, liver, or prostate cancer with measurable disease by RECIST criteria. Potential patients will have progressed after standard therapy, have no effective therapy, or have refused standard therapy. Any prior treatment must have been completed at least 4 weeks before the 1st dose of study medication.
Treatment for Malignant Ascites due to Recurrent Disease
A Prospective, Phase II Trial of Intravenous Bevacizumab (Avastin) for the Prevention of Recurrent Malignant Ascites (H-21728): The purpose of this study is to determine the effectiveness of using Bevacizumab in the prevention of recurrent malignant ascites. Patients must have persistent or symptomatic ascites secondary to any histologically confirmed tumor type that is not amenable to cytoreductive surgery or additional chemotherapy.
For more information: http://clinicaltrials.gov/ct2/show/NCT00908219
OPENING SOON
Myeloma
First-Line Treatment for Multiple Myeloma (H-23241)
S0777: A Randomized Phase III Trial of CC-5013 (Lenalidomide) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant: S0777 compares progression-free survival of patients with newly diagnosed multiple myeloma (MM) treated with lenalidomide + low-dose dexamethasone (LLD), with or without bortezomib. Patients must have newly diagnosed MM with measurable disease, with no prior chemotherapy for myeloma. After induction therapy, patients receive maintenance therapy (LLD) until disease progression.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00644228
Myeloproliferative Disorder and Myelodysplastic Syndrome
H-8701: CD34-selection for ex vivo T-cell depletion of mobilized peripheral blood stem cells for recipients of HLA haploidentical related donor stem cell grafts receiving intensive conditioning: This study uses a monoclonal antibody and high dose chemotherapy and radiotherapy combined with a haploidentical allogeneic stem cell transplantation to treat pediatric patients with hematologic malignancies.
http://www.clinicaltrials.gov/ct2/show/NCT00368355
Nasopharyngeal Carcinoma
H21000: Administration Of LMP1- And LMP-Specific Cytotoxic T-Lymphocytes To Patients With EBV-Positive Nasopharyngeal Carcinoma: This study uses T cells specific for the EBV antigens LMP1 and 2 to treat patients with EBV positive NPC.
Neuroblastoma
H-13149: Administration of Peripheral Blood T-Cells and EBV Specific CTLs Transduced to Express GD-2 Specific Chimeric T Cell Receptors to Patients with Neuroblastoma: This study uses EBV and 14G2a (a neuroblastoma specific antibody) specific T-Lymphocytes to treat patients with neuroblastoma.
http://www.clinicaltrials.gov/ct2/show/NCT00085930
Non-Hodgkin Lymphoma
Relapsed and/or Refractory Non-Hodgkin Lymphoma Study (COMBOSTAT) (H-24285): The purpose of this study is to determine the rate of response to the drugs bortezomib (Velcade) and vorinostat (Zolinza), when used in combination, in patients with relapsed (recurrent) and/or refractory (difficult to treat) non-Hodgkin Lymphoma, and to determine the safety and tolerability of this regimen. Patients must have NHL, and have received at least 2 prior therapies with resistant disease.
For more information: http://clinicaltrials.gov/ct2/show/NCT00837174
OPENING SOON
H6676: Administration of EBV specific Cytotoxic T Lymphocytes to Recipients of Mismatched-related or Phenotypically Similar Unrelated Donor Marrow Grafts: This study uses allogeneic EBV specific T-Lymphocytes to prevent or treat EBV related infection following an allogeneic stem cell transplant.
http://www.clinicaltrials.gov/ct2/show/NCT00058812
H-9936: Administration Of LMP Specific Cytotoxic T-Lymphocytes To Patients With Relapsed EBV-Positive Hodgkin Disease: This study uses autologous EBV specific T-Lymphocytes targeting the EBV proteins LMP1 and LMP2 to treat lymphoma.
http://www.clinicaltrials.gov/ct2/show/NCT00671164
H-17946: Administration of TGF-b Resistant LMP-Specific Cytotoxic T-Lymphocytes to Patients with Relapsed EBV-Positive Lymphoma: This study uses EBV specific T-Lymphocytes with a gene inserted to render them resistant to TGF-b to treat lymphoma.
http://www.clinicaltrials.gov/ct2/show/NCT00675571
H-19275: Administration of LMP1- AND LMP2-specific Cytotoxic T-Lymphocytes following CD45 Antibody to Patients with Relapsed EBV-Positive Hodgkin’s or non-Hodgkin’s Lymphoma: This study uses a combination of monoclonal antibodies and autologous EBV specific T-Lymphocytes to treat lymphoma.
H19384: Phase I Study Of CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin’s Lymphoma And Chronic Lymphocytic Leukemia: This study uses a chimeric receptor made from T cells that kill tumor cells and an antibody called anti-CD19 that sticks to lymphoma cells to try to treat non-Hodgkin’s lymphoma and CLL.
http://www.clinicaltrials.gov/ct2/show/NCT00608270
H22899: Phase I Study of the Administration of Peripheral Activated T-Cells or EBV specific CTLs Expressing CD19 Chimeric Receptors for Advanced B-Cell non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia: This study uses a chimeric receptor made from T cells that kill tumor cells and an antibody called anti-CD19 that sticks to lymphoma cells to try to treat non-Hodgkin’s lymphoma and CLL.
http://www.clinicaltrials.gov/ct2/show/NCT00709033
Ovarian
Maintenance Therapy for Ovarian Cancer in Remission
A Study of GDC-0449 (Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission (H-23714): The study is for patients with recurrent ovarian cancer in a second or third complete remission. Patients will be randomized in a 1:1 ratio to either GDC-0449 or placebo. Randomization will be stratified based on whether their cancer is in a second or third complete remission. Patients must have completed their most recent chemotherapy no less than 3 weeks and no more than 14 weeks prior to randomization.
For more information: http://clinicaltrials.gov/ct2/show/NCT00739661
Pancreas
First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer (H-17553)
A Randomized, Phase II/III, Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer: The purpose of this study is to assess the safety and effectiveness of TNFerade Biologic with 5-FU and radiation therapy to treat patients with unresectable locally advanced pancreatic cancer. Patients must have measurable disease, no metastases, and no previous treatment for pancreatic cancer. All participants will receive chemoradiation; two thirds of the participants will also receive TNFerade Biologic and the remaining one third will receive chemoradiation alone. After the chemoradiation treatment, all patients will receive maintenance therapy of gemcitabine or gemcitabine + erlotinib.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00051467
First-Line Treatment for Metastatic Pancreas Cancer (H-25342)
S0727: A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs Gemcitabine + Erlotinib as First-Line Treatment in Patients With Metastatic Pancreatic Cancer
[Note: Only the Phase II portion of this study is open at this center.] The primary objective of the study is to evaluate chemotherapy plus IMC-A12 (a monoclonal antibody) versus chemotherapy alone, in patients with metastatic pancreatic cancer. Patients must have metastatic pancreatic cancer that cannot be removed by surgery, and patients must not have received prior chemotherapy. Patients are randomized to gemcitabine/erlotinib alone or gemcitabine/erlotinib plus IMC-A12. Treatment repeats every 4 weeks until disease progression or unacceptable toxicity.
For more information: http://clinicaltrials.gov/ct2/show/NCT00617708
Adjuvant Treatment for Resected Non-Metastatic Pancreatic Cancer (H-20777)
A Phase 2 Double-Blind, Placebo-Controlled, Multi-center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharaomyces cerevisiae Gemcitabine Regimen Versus a Gemcitabine Regimen with Placebo, in Patients with Post-resection R0/R1 Pancreatic Cancer with Tumor Sequence Confirmation of Ras Mutations: This study will assess the safety and efficacy of GI-4000 as adjuvant treatment in patients with resected pancreatic cancer. Patients must have resectable pancreatic cancer with post-resection confirmation of nonmetastatic disease and confirmed R0 or F1 status post-resection. No other prior therapy for pancreatic cancer is allowed. Tumor sample will be tested, and must have product-related Ras mutation. All patients will receive gemcitabine, plus either GI-4000 or placebo.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00300950
Prostate Cancer
Immunotherapy for Metastatic Prostate Cancer (H-17274)
Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine: This Phase I study is designed to evaluate the safety and biology of the NY-ESO-1/LAGE-1 vaccine, with intent to offer a therapeutic advantage. Patients must have metastatic, hormone-refractory prostate cancer, with a baseline PSA > 10 ng/ml and must continue treatment with LHRH agonist during the study. Patients will be genotyped, and must have one of the following haplotypes: HLA-DR4, DR13, DP4, or HLA-A2. Six subcutaneous vaccine injections will be administered every other week for 12 weeks.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00711334
Zometa/Placebo for Metastatic Prostate Cancer (H-19541)
C90202: A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone: This trial examines the ability of zometa to prevent bone-related events in patients receiving androgen deprivation therapy for prostate cancer with bone metastases. Patients are randomized to zometa or placebo, until disease progression. At progression, patients can proceed to open-label zometa therapy.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00079001
First-Line Treatment for Hormone-Refractory Metastatic Prostate Cancer (H-23103)
S0421: Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer: This study compares progression-free and overall survival in metastatic prostate cancer patients receiving docetaxel + prednisone, plus either atrasentan or placebo. Patients must have hormone-refractory metastatic prostate cancer with evidence of bone metastases by bone scan or MRI.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00134056
Penile Rehabilitation after Radical Prostatectomy
Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01) (H-21148): The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Men scheduled for surgery to remove the prostate will be given the opportunity to take part in this study. Patients will be randomized to one of two groups: testosterone gel plus Viagra, or placebo plus Viagra. Patients will be followed for up to one year after surgery.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00848497
Contact: Sharon Harrison, 713-798-2240, sharons@bcm.edu
Health-Related Quality of Life in Gay Men with Localized Prostate Cancer
Patient-Reported Outcomes for Gay Men with Localized Prostate Cancer (H-21892): Patients must have a diagnosis of localized prostate cancer (advanced disease is not allowed), and be self-identified as gay. Patients complete a web-based survey about their disease (biopsy Gleason score, PSA at diagnosis, and T-stage), treatment (treatment type, time since treatment, and use of healthcare services), symptom distress, and psychosocial factors that affect their health-related quality of life. The data will be used to provide the information necessary to tailor an existing prostate cancer survivorship intervention to address the specific needs of gay men with prostate cancer.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00828633
Contact: David Latini, 877-794-7852, CancerOutComes@bcm.edu
Symptom Management in African-American Men with Localized Prostate Cancer
Prostate Cancer Symptom Management for Low Literacy Men (H-19323): The goal of this study is to develop a symptom management intervention for African-American men treated for localized prostate cancer, with a particular emphasis on low health literacy men. Participants are interviewed by the investigator over the phone or meet the investigator at the Michael E. DeBakey Veterans Affairs Medical Center prostate cancer clinic.
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00767845
Contact Information: David Latini, PhD, 877-794-7852, canceroutcomes@bcm.edu
Transplant Studies for Hematological Malignancies
H-8701: CD34-selection for ex vivo T-cell depletion of mobilized peripheral blood stem cells for recipients of HLA haploidentical related donor stem cell grafts receiving intensive conditioning: This study uses a monoclonal antibody and high dose chemotherapy and radiotherapy combined with haploidentical allogeneic stem cell transplantation to treat pediatric patients with hematologic malignancies.
H-11892: A Current Practice Study Of Rituxan In Patients Receiving BEAM Chemotherapy And Autologous Blood Stem Cell Transplantation For High Risk Lymphoma And Hodgkin's Disease: This study uses a monoclonal antibody and high dose chemotherapy combined with autologous stem cell transplantation.
H21079 T-Regulatory Cell Kinetics in Patients With Leukemia, Advanced Hodgkin or Non-Hodgkin Lymphoma, or Myelodysplastic/Myeloproliferative Disease Receiving Alemtuzumab and Undergoing Stem Cell Transplantation From HLA Mismatched-Related Donors or HLA Matched-Unrelated Donors: This study uses alemtuzumab as part of conditioning therapy to patients undergoing stem cell transplantation from mismatched-related donors or from matched-unrelated donors and evaluates T-regulatory cell recovery.
Reconstituting Immunity Post Transplant
H6676: Administration of EBV specific Cytotoxic T Lymphocytes to Recipients of Mismatched-related or Phenotypically Similar Unrelated Donor Marrow Grafts: This study uses allogeneic EBV specific T-Lymphocytes to prevent or treat EBV related infection following an allogeneic stem cell transplant.
http://www.clinicaltrials.gov/ct2/show/NCT00058812
H12683: Virus Specific Cytotoxic T-Lymphocytes for the Prophylaxis of CMB after Allogeneic Stem Cell Transplant: A Dose-Finding Trial: This study uses allogeneic CMV specific T-Lymphocytes to prevent CMV related infection following an allogeneic stem cell transplant.
http://www.clinicaltrials.gov/ct2/show/NCT00078533
H22994: Most Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lyphocytes (CTL) to treat Persistent Reactivation or Infection with Adenovirus, CMV and EBV after Hemopoietic Stem Cell Transplantation (SCCT Protocol): This study uses allogeneic Epstein Barr virus (EBV), cytomegalovirus (CMV) and adenovirus (AdV) T cells to treat persistent viral infections following an allogeneic Stem Cell Transplant. The cells will be obtained from a donor that is a partial match with the patient and the transplant donor.
http://www.clinicaltrials.gov/ct2/show/NCT00711035
H23668: Adoptive transfer of Cord blood T cells to prevent and treat CMV and Adenovirus infections after Transplantation: This study uses cytomegalovirus (CMV) and adenovirus (AdV) T cells to treat AdV and/or CMV infection following a cord blood transplant.
H21580: A Phase I Study Evaluating the use of Allodepleted T Cells Transduced with Inducible Caspase 9 Suicide Gene After Haploidentical Stem Cell Transplantation: This study is an add on study in which patients who have received a haploidentical stem cell transplant are eligible to receive allodepleted T cells following engraftment. The T-cells may help the immune system recover so that the body can fight infections.
http://www.clinicaltrials.gov/ct2/show/NCT00710892