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| Sponsor: | City of Hope Medical Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | City of Hope Medical Center |
| 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: | Primary Purpose: 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: | October 2012 (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
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00569985 History of Changes |
| Other Study ID Numbers: | 04047, P30CA033572, CHNMC-04047 |
| Study First Received: | December 7, 2007 |
| Last Updated: | October 18, 2011 |
| 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 |
|
Lymphoma Lymphoma, AIDS-Related Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Carmustine Cyclophosphamide Etoposide Lenograstim |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Adjuvants, Immunologic |