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Sponsors and Collaborators: |
AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00598169 |
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
It is not yet known whether giving bortezomib together with combination chemotherapy is more effective with or without rituximab in treating AIDS-related non-Hodgkin lymphoma.
PURPOSE: This clinical 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.
Condition | Intervention |
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Lymphoma |
Biological: rituximab Drug: bortezomib Drug: carboplatin Drug: dexamethasone Drug: etoposide Drug: ifosfamide Genetic: polymerase chain reaction Genetic: western blotting Other: questionnaire administration |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | 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 |
Estimated Enrollment: | 18 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed relapsed or refractory HIV-associated non-Hodgkin lymphoma (NHL)
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled intercurrent illness including, but not limited to, any of the following:
Ongoing or active infection
Acute active HIV-associated opportunistic infection requiring antibiotic treatment
Active hepatitis B infection (hepatitis B surface antigen-positive), unless 1 of the following criteria are met:
PRIOR CONCURRENT THERAPY:
United States, California | |
Rebecca and John Moores UCSD Cancer Center | Recruiting |
La Jolla, California, United States, 92093-0658 | |
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354 cancercto@ucsd.edu |
Study Chair: | Erin G. Reid, MD | University of California, San Diego |
Investigator: | William Wachsman, MD | University of California, San Diego |
Study ID Numbers: | CDR0000581078, AMC-053 |
Study First Received: | January 9, 2008 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00598169 History of Changes |
Health Authority: | Unspecified |
AIDS-related diffuse large cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma AIDS-related immunoblastic large cell lymphoma |
AIDS-related lymphoblastic lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma AIDS-related small noncleaved cell lymphoma |
Anti-Inflammatory Agents Dexamethasone Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Central Nervous System Lymphoma, Primary Hormones Lymphoblastic Lymphoma Etoposide phosphate Lymphoma, Large-cell, Immunoblastic Kaposi Sarcoma Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell |
Alkylating Agents Lymphoma Etoposide Dexamethasone acetate Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Sarcoma, Kaposi Bortezomib Carboplatin Small Non-cleaved Cell Lymphoma Glucocorticoids Protease Inhibitors Lymphatic Diseases |
Anti-Inflammatory Agents Dexamethasone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Alkylating Agents Etoposide Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type |
Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Bortezomib Gastrointestinal Agents Enzyme Inhibitors Carboplatin Glucocorticoids Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Neoplasms Ifosfamide Autonomic Agents Antineoplastic Agents, Alkylating |