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| Sponsor: | Beckman Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00569985 |
Purpose
RATIONALE: Placing a gene from HIV into a patient's stem cells may make the body build an immune response to kill cancer cells in patients with AIDS-related lymphoma.
PURPOSE: This clinical trial is studying the side effects and best dose of gene therapy in treating patients undergoing a stem cell transplant for intermediate-grade or high-grade AIDS-related lymphoma.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Biological: filgrastim Biological: gene therapy Drug: carmustine Drug: cyclophosphamide Drug: etoposide Procedure: autologous hematopoietic stem cell transplantation Procedure: in vitro-treated peripheral blood stem cell transplantation |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study of Safety and Feasibility of Stem Cell Therapy for Aids Lymphoma Using Stem Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs |
| Estimated Enrollment: | 5 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients undergo hematopoietic progenitor cell (HPC) mobilization with a combination of chemotherapy (using their prior antilymphoma regimen or cyclophosphamide) and filgrastim (G-CSF). Approximately 24 hours after completion of chemotherapy, patients receive G-CSF subcutaneously daily until the last apheresis is completed. A portion of the apheresis products are transduced with rHIV7-shI-TAR-CCR5RZ.
Patients receive high-dose conditioning regimen comprising carmustine IV over 4 hours on days -7 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2. Patients receive rHIV7-shI-TAR-CCR5RZ-transduced autologous HPCs IV over approximately 30 minutes on day 0 and standard non-transduced autologous HPCs IV over 30 minutes on day 1.
NOTE: Patients continue their anti-HIV regimen during antilymphoma chemotherapy, as prescribed by the physician managing their HIV infection; patients stop the anti-HIV regimen at the time of initiating HPC mobilization with G-CSF and resume it after the last apheresis is completed; patients also stop the anti-HIV regimen on day -7 (initiation of high-dose conditioning) and resume it on day 3 (post-transplantation).
After completion of study therapy, patients are followed periodically for up to 15 years.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
HIV seropositive at or before the time of lymphoma diagnosis
Must be on a multi-drug anti-HIV regimen (excluding zidovudine [AZT]) and have an HIV viral load < 50,000 copies/mL by RT-PCR at the time of study enrollment
Meets 1 of the following criteria:
Biopsy proven intermediate- or high-grade non-Hodgkin lymphoma, meeting 1 of the following criteria:
Biopsy-proven Hodgkin lymphoma, meeting 1 of the following criteria:
No active CNS lymphoma
PATIENT CHARACTERISTICS:
No active CMV retinitis or other active CMV-related organ dysfunction
No perceived inability to directly provide informed consent
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Study Chair: | Amrita Y. Krishnan, MD | Beckman Research Institute |
More Information
| Study ID Numbers: | CDR0000577423, CHNMC-04047 |
| Study First Received: | December 7, 2007 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00569985 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 small noncleaved cell lymphoma HIV-associated Hodgkin lymphoma Treatment Experienced |
|
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Lymphoma, B-Cell Lymphoma, AIDS-Related Therapeutic Uses Etoposide Lymphoma Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Carmustine Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Antirheumatic Agents Antineoplastic Agents, Phytogenic |