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Dan L. Duncan Cancer Center

Houston, Texas

BCM has 25 departments and more than 90 research and patient-care centers.
Dan L. Duncan Cancer Center
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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.


Bladder Cancer

Surgical Trial for Invasive Urothelial (Bladder) Cancer

S1011: Phase III Surgical Trial to Evaluate the Benefit of A Standard Versus An Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy For Muscle Invasive Urothelial Cancer (H-29212): This study will investigate whether patients experience longer disease-free survival when they undergo the standard surgical treatment alone or the standard surgical treatment and the removal of additional lymph nodes. Patients must have certain confirmed stages of urothelial carcinoma of the bladder that requires radical cystectomy for treatment. Patients will be randomized to one of the treatment options during the surgical procedure and be followed for 6 years from the time of surgery. For more information: http://www.clinicaltrials.gov/ct2/show/NCT01224665

CALGB-90601: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma (H-27272): This randomized phase III trial is studying gemcitabine, cisplatin, and bevacizumab to see how well they work compared with gemcitabine, cisplatin, and placebo in treating patients with advanced urinary tract cancer. Patients must have confirmed transitional cell carcinoma of the urinary tract, which is unresectable or metastatic or locally advanced disease. Patients are randomized to one of two arms: Arm 1 patients receive cisplatin, gemcitabine, and placebo; Arm 2 patients receive cisplatin, gemcitabine, and bevacizumab. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00942331

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: Helen Kopelen, 713-798-8514, kopelen@bcm.edu


Colon and Rectal Cancer

CALGB-80702: A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer (H-27389): This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. Patients must have stage III colon adenocarcinoma, which must be completely resected with no evidence of residual lymph node disease or metastatic disease. Patients will be randomized into one of four treatment arms. For more information: http://www.clinicaltrials.gov/ct2/show/NCT01150045

Treatment for Locally Advanced Rectal Cancer

N1048 (PROSPECT): A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiaton versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (H-32928, VA-H-32929): This study will investigate how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery. Patients must have a diagnosis of locally advanced rectal adenocarcinoma and have not received any prior radiation therapy or any chemotherapy within 5 years. Patients will be randomized to one of two treatment arms to receive chemotherapy alone or chemotherapy plus radiation followed by surgery. For more information: http://clinicaltrials.gov/show/NCT01515787


Gastric/Stomach

Chemo for Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

S1201: A Randomized Phase II Pilot Study Prospectively Evaluation Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric, or Gastroesophageal Junction (GEJ) Cancer (H-31960, VA-H-31961): This trial will study how well FOLFOX (oxaliplatin, leucovorin, and fluorouracil) works compared to irinotecan and docetaxel in treating esophageal, gastric, or gastroesophageal junction cancer. The study will look at levels of a gene called ERCC1 in subjects to see how subjects respond to the treatments. Eligible subjects must not have received treatment for metastatic or unresectable disease and have no brain metastases. Sunjects will be randomized to either FOLFOX or irinotecan and docetaxel and will continue with their assigned treatment until their disease progresses.

For more information: http://clinicaltrials.gov/show/NCT01498289


Head and Neck Cancer

Chemotherapy for Recurrent/Metastatic Head and Neck Center

E1305: A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer (H-26189):This study compares the effects of two different standard of care chemotherapies (cisplatin/docetaxel or cisplatin/5-FU) with or without the addition of bevacizumab to learn which treatment is better. Patients must have recurrent or metastatic Squamous Cell Cancer of the Head and Neck, not have received any prior therapy for recurrent/metastatic disease, and not have previously taken bevacizumab. After the treating physician selects which chemotherapy the patient will receive (cisplatin/docetaxel or cisplatin/5-FU), patients are randomized to either chemotherapy alone, or chemotherapy + bevacizumab. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00588770

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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00848042.
Contact Contact Dr. Teresa Hayes at 713-794-7368 or thayes@bcm.edu.


Hodgkin Lymphoma

Blood Tissue Samples from Patients with B-Cell Lymphomas

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. For more information: 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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00675571


Kidney Cancer (Renal)

Everolimus/Placebo for Renal Cancer following Surgery

S0931: EVEREST - EVErolimus for Renal Cancer Ensuring Surgical Therapy, A Phase III Study (H-29137): This study will compare whether adding the oral drug everolimus vs. placebo for one year after surgery to remove kidney cancer will improve recurrence-free survival. The current standard treatment is monitoring after surgery. Patients must have had a full surgical resection with negative margins and all positive lymph nodes removed. Eligible patients must not have evidence of metastatic disease. All patients with be randomized to either everolimus or placebo for one year and then be followed for a total of 10 years from registration.
For additional information: http://clinicaltrials.gov/show/NCT01120249

Leukemia

Chemotherapy + Pravastatin for Relapsed Acute Myelogenous Leukemia

S0919: A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Poor-Risk Acute Myelogenous Leukemia (AML) (H-28166): The purpose of this study is to determine the effects of adding Pravastatin to standard of care therapy (Idarubicin and Ara-C) for poor-risk AML. Patients must either have a previous diagnosis of AML that has relapsed after complete remission (CR) or complete remission with incomplete blood counts (CRi) that lasted less than six months or a previous diagnosis of MDS that has transformed to AML. All patients will receive the same treatment of induction and consolidation with Idarubicin, Ara-C and Prevastatin. For additional information: http://www.clinicaltrials.gov/ct2/show/NCT00840177

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. For more information: 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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00058825

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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00840853


Liver Cancer

Chemotherapy for Advanced/Metastatic Liver Cancer

C80802: Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) (H-26756): This study compares the effects of standard of care therapy (sorafenib) with or without the addition of doxorubicin to learn which treatment is better. Patients must have locally advanced or metastatic hepatocellular carcinoma (HCC), and not have received any prior therapy for metastatic disease, or liver/bone marrow transplants. Patients are randomized to 1 of 2 treatments: sorafenib + doxorubicin; or sorafenib alone. For more information: http://www.clinicaltrials.gov/ct2/show/NCT01015833


Lung Cancer

First-Line Treatment for Advanced Non-Small Cell Lung Cancer (H-25596)

S0819: A Randomized Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC): This study compares the effects of cetuximab on newly diagnosed Stage IV advanced primary NSCLC or recurrent disease after previous surgery and/or irradiation. Patients are randomized to 1 of 4 groups for 6 cycles: chemotherapy and bevacizumab; chemotherapy only; chemotherapy, cetuximab, and bevacizumab; or chemotherapy and cetuximab until disease progression. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00946712

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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00889954


Metastatic Disease


Myeloma

Treatment for Relapsed Multiple Myeloma (H-27371)

A controlled, parallel-group, randomized, open-label study to evaluate two lenalidomide dose regimes when used in combination with lose dose dexamethasone for treatment of subjects with relapsed multiple myeloma (H-27371) This is a multi-center, controlled, open-label, randomized study intended to select a tolerable dose regimen with acceptable efficacy of Lenalidomide, when used in combination with Dexamethasone. Subjects will receive either oral Lenalidomide 25 mg or Lenalidomide 15 mg once daily for days 1-21 out of a 28 day cycle. The subjects must have relapsed or refractory disease requiring 2nd or 3rd line treatment. The clinical trial is currently being offered at the Michael E. DeBakey Veterans Affairs Medical Center. For more information: http://www.clinicaltrials.gov/ct2/show/NCT01380106

First Line Treatment for Multiple Myeloma

A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone with or without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma (H-31535): The purpose of this study is to look at the effects of adding elotuzumab to lenalidomide and dexamethasone in patients with previously untreated multiple myeloma. Patients must have newly diagnosed, untreated, symptomatic, documented myeloma and measurable disease. Subjects will take either lenalidomide and dexamethasone by mouth along with dexamethasone by IV, or they will take lenalidomide and dexamethasone by mouth along with dexamethasone by IV as well as elotuzumab. For more information: http://www.clinicaltrials.gov/ct2/show/NCT01335399


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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00368355


Non-Hodgkin Lymphoma

Relapsed/Refractory AIDS-Related NHL

AMC-053: Safety and Efficacy Pilot Trial of the Anti-Viral and Anti-Tumor Activity of Velcade Combined With (R)ICE in Subjects With EBV and/or HHV-8 Positive Relapsed/Refractory AIDS-Associated Non-Hodgkin's Lymphoma (H-26042): This trial is studying giving bortezomib together with dexamethasone, ifosfamide, carboplatin, and etoposide to see how well it works with or without rituximab in treating patients with relapsed or refractory AIDS-related non-Hodgkin lymphoma. Patients much have confirmed relapsed or refractory HIV-associated NHL, must have documented HIV seropositivity, and must have EBV- and/or HHV-8-positive infection within the lymphoma. For more information: http://www.clinicaltrials.gov/ct2/show/study/NCT00598169

Maintenance Therapy - Diffuse Large B-cell Lymphoma

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. For more information: 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. For more information: 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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00675571

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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00608270


Pancreas

Treatment for Borderline Resectable and Unresectable Pancreatic Cancer

NLG-0505: A Phase III Study of FOLFIRINOX With or Without HyperAcute® - Pancreas (algenpantucel-L) Immunotherapy in Subjects with Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (H-32864): The purpose of this study is to see whether adding the investigational immunotherapy to the standard of care regimen FOLFIRINOX increases survival of patients with borderline resectable or unresectable pancreatic cancer. Eligible patients must have a histological diagnosis of pancreatic cancer without distant metastases and disease defined as borderline or locally advanced unresectable as determined by the NCCN guidelines. Patients will be randomized to receive FOLFIRINOX with or without HyperAcute® - Pancreas immunotherapy. For more information: http://clinicaltrials.gov/show/NCT01836432


Prostate Cancer

Treatment for Metastatic Prostate Cancer

S1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer (H-32729, VA H-32730): This study will investigate whether adding an investigational drug, TAK-700, to Androgen Deprivation Therapy (ADT) can reduce trace androgen levels and therefore extend overall survival compared to standard ADT alone. Patients must have adenocarcinoma of the prostate and metastatic disease at the time of initiation of ADT. Patients will be randomized to one of two treatment arms to receive ADT plus TAK-700 or ADT plus bicalutamide.
For more information: http://clinicaltrials.gov/show/NCT01809691

Open-Label Treatment for Localized Prostate Cancer

Phase II, Open-Label Study of Metformin in Combination With Simvastatin for Men With Prostate Carcinoma and a Rising Serum Prostate-Specific Antigen Level After Radical Prostatectomy and/or Radiation Therapy (H-28936, VA: H-28989): This study will investigate the impact of metformin, together with simvastatin, on the pattern of rise of PSA in men with biochemical recurrence after definitive therapy for localized prostate cancer, the goal is to delay the need for initiation of androgen deprivation therapy (ADT). Patients must have undergone primary therapy (prostatectomy or primary radiation) for biopsy-proven adenocarcinoma of the prostate and now have biochemical-only recurrence. All patients will take metformin twice daily and simvastatin once daily. This study includes correlative studies.
For more information: http://clinicaltrials.gov/ct2/show/NCT01561482

Sarcoma

None available at this time


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.

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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT00058812

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. For more information: http://www.clinicaltrials.gov/ct2/show/NCT01017705

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