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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00538187 |
RATIONALE: Obatoclax may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Bortezomib and obatoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of obatoclax when given together with bortezomib and to see how well they work in treating patients with aggressive relapsed or recurrent non-Hodgkin lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: bortezomib Drug: obatoclax mesylate Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of GX15-070 (NSC # 729280) and Bortezomib in Aggressive Relapsed/Recurrent Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 18 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Pharmacokinetic evaluations of obatoclax mesylate are conducted in all patients during the first course.
Archival (pre-study) surgical specimens, including fixed paraffin-embedded diagnostic tissue blocks, are collected for immunohistochemical analysis of the Bcl-2 family members, p53, Noxa, and Puma proteins. Serial blood samples are collected at baseline, day 8, and day 15 for cytochrome C analysis via enzyme-linked immunosorbent assay and plasma and buffy coat analysis.
After completion of study treatment, patients are followed for 26 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically or cytologically confirmed relapsed or refractory non-Hodgkin lymphoma for which standard curative or palliative measures do not exist or are no longer effective, including any of the following subtypes:
Must have had at least one prior chemotherapeutic regimen
At least 3 months since prior autologous stem cell transplantation and relapsed (≥ 1 year since prior allogeneic transplantation and relapsed)
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled concurrent medical condition or illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
City of Hope Medical Group | Recruiting |
Pasadena, California, United States, 91105 | |
Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com | |
Contra Costa Regional Medical Center | Recruiting |
Martinez, California, United States, 94553 | |
Contact: Sharon Hiner, MD 925-370-5114 shiner@hsd.co.contra-costa.ca.us | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90089-9181 | |
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
Veterans Affairs Outpatient Clinic - Martinez | Recruiting |
Martinez, California, United States, 94553 | |
Contact: Ted Wun, MD 925-372-2062 | |
United States, Pennsylvania | |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033-0850 | |
Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 |
Study Chair: | Joseph M. Tuscano, MD | University of California, Davis |
Study ID Numbers: | CDR0000566357, CCC-PHI-58 |
Study First Received: | October 1, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00538187 |
Health Authority: | Unspecified |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent marginal zone lymphoma |
recurrent mantle cell lymphoma recurrent adult diffuse large cell lymphoma recurrent small lymphocytic lymphoma |
Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Lymphoma, Mantle-Cell Bortezomib Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Mantle cell lymphoma |
Recurrence Lymphoma, large-cell Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |