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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00641381 |
RATIONALE: Giving high-dose chemotherapy drugs, such as carmustine, etoposide, and cyclophosphamide, before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells that were collected from the patient's blood are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This clinical trial is studying the side effects of giving high-dose carmustine, etoposide, and cyclophosphamide together with a stem cell transplant and to see how well it works in treating patients with HIV-associated lymphoma.
Condition | Intervention |
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Lymphoma |
Drug: carmustine Drug: cyclophosphamide Drug: etoposide Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: pharmacological study |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | High Dose Chemotherapy and Combination Anti-HIV Therapy for HIV-Associated Hodgkin's and Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 25 |
Study Start Date: | March 2000 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
OUTLINE: Patients undergo leukapheresis to obtain peripheral blood stem cells (PBSCs) for transplantation. At least 5 days later, patients with an adequate number of collected cells proceed to high-dose chemotherapy.
After completion of study treatment, patients are followed at approximately 30 days and 100 days, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Ages Eligible for Study: | 10 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-confirmed lymphoma, meeting 1 of the following criteria:
Hodgkin lymphoma of any subtype except nodular L&H lymphocyte predominant
Intermediate-grade or high-grade non-Hodgkin lymphoma* (working formulation groups D-H and J)
Must be on a multi-drug regimen (excluding azidothymidine [AZT])* to maintain HIV viral load < 50,000 genome copies (gc)/mL
Patients who are not in complete remission must have measurable disease defined as the following:
Patients with a history of positive CSF cytology that has become negative with intrathecal chemotherapy are eligible
PATIENT CHARACTERISTICS:
Inclusion criteria:
LVEF > 50% by 2-D echocardiogram or MUGA scan
Patients who are hepatitis C antibody positive or hepatitis B surface antigen positive without clinical evidence of cirrhosis will be eligible after further evaluation of viral loads
Exclusion criteria:
Active CMV retinitis or other CMV-related organ dysfunction
Any prior malignancy except treated basal cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
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 |
Principal Investigator: | Amrita Y. Krishnan, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000589621, CHNMC-99067 |
Study First Received: | March 21, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00641381 |
Health Authority: | Unspecified |
stage III adult Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage IV childhood Hodgkin lymphoma recurrent childhood lymphoblastic lymphoma recurrent mantle cell lymphoma recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma recurrent adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma AIDS-related diffuse large cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related immunoblastic large cell lymphoma AIDS-related lymphoblastic lymphoma AIDS-related small noncleaved cell lymphoma |
Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage III grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma |
Hodgkin's disease Hodgkin lymphoma, adult Cutaneous T-cell lymphoma Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Cyclophosphamide Etoposide phosphate Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Lymphoma, large-cell Burkitt's lymphoma Leukemia Lymphoma, AIDS-Related Lymphoma, T-Cell |
Lymphoma, Large-Cell, Immunoblastic Etoposide Hodgkin Disease Lymphoma Lymphoma, AIDS-related Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia-Lymphoma, Adult T-Cell Carmustine Acquired Immunodeficiency Syndrome Lymphoblastic lymphoma Mantle cell lymphoma Recurrence Lymphatic Diseases HIV Infections |
Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |