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Sponsors and Collaborators: |
Ontario Clinical Oncology Group (OCOG) Hoffmann-La Roche |
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Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00799136 |
No standard regimen currently exists for the treatment of AIDS-related lymphoma. Based on the encouraging NCI results with DA-EPOCH, the US AIDS Malignancy Consortium is currently administering a phase II randomized protocol comparing EPOCH with sequential versus concurrent rituximab (AMC protocol 034). In this AMC trial, the decision to co-administer cART is left to the discretion of the treating physician and the patient. While the AMC phase II study may establish an acceptable chemotherapy regimen suitable for further study in a phase III randomized trial, the results will not address adherence, pharmacokinetic interactions or the role of cART in AIDS-related lymphoma. The contribution of cART to the anti-lymphoma efficacy of any regimen needs to be formally studied. Our proposed trial to demonstrate the feasibility of co-administering cART with chemotherapy would justify the use of combined therapy in future AMC/International phase III protocols.
Condition | Intervention | Phase |
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Lymphoma, AIDS Related HIV Infections |
Drug: R-EPOCH and cART |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Feasibility Study of CO-Administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of Acquired Immunodeficiency Syndrome (AIDS)-Related Lymphoma |
Estimated Enrollment: | 18 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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One
Rituxan with EPOCH and Antiretrovirals
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Drug: R-EPOCH and cART
This is a prospective, single-arm, multi-centre, phase II trial of immuno-chemotherapy (rituximab and EPOCH) with mandatory combination antiretroviral therapy for initial treatment of AIDS-related lymphoma.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contact: Betsy A MacKinnon, HBA MSc | 905 527 2299 ext 42606 | mackinn@mcmaster.ca |
Contact: Donna McCarty | 905 527 2299 ext 42605 | mccartyd@mcmaster.ca |
Canada, Ontario | |
Odette Cancer Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Matthew Cheung, Dr. 416 480 5847 matthew.cheung@sunnybrook.ca | |
Principal Investigator: Matthew Cheung, Dr. |
Principal Investigator: | Matthew Cheung, Dr. . | Odette Cancer Centre |
Responsible Party: | Ontario Clinical Oncology Group ( Dr. Mark Levine Director OCOG ) |
Study ID Numbers: | OCOG-2007-CATCH, CIHR FRN 79390 |
Study First Received: | November 26, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00799136 |
Health Authority: | Canada: Health Canada |
Lymphoma Large B Cell Diffuse Acquired Immunodeficiency |
Lymphoma, AIDS-related Prednisone Efavirenz Sexually Transmitted Diseases, Viral Immunoproliferative Disorders Rituximab Acquired Immunodeficiency Syndrome Vincristine Cyclophosphamide Etoposide phosphate Doxorubicin Immunologic Deficiency Syndromes |
Virus Diseases Lymphoma, B-Cell Lymphatic Diseases Lymphoma, AIDS-Related HIV Infections B-cell lymphomas Sexually Transmitted Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Etoposide Lymphoma Retroviridae Infections |
Neoplasms RNA Virus Infections Neoplasms by Histologic Type Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |