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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: | NCT00005824 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have recurrent or refractory AIDS-related lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma |
Study Start Date: | November 2000 |
OBJECTIVES:
OUTLINE: Patients receive mobilization chemotherapy consisting of cyclophosphamide IV over 2 hours followed 2 days later by daily filgrastim (G-CSF) subcutaneously (SC) until blood counts recover. Patients then undergo leukopheresis to collect CD34+ cells.
Patients receive conditioning chemotherapy consisting of oral busulfan every 6 hours on days -7, -6, -5, and -4 for a total of 14 doses and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo autologous stem cell infusion on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover.
Patients are followed monthly for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Intermediate- or high-grade non-Hodgkin's lymphoma or Hodgkin's disease
Sensitive to most recent chemotherapy
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02129 |
Study Chair: | David T. Scadden, MD | Massachusetts General Hospital |
Study ID Numbers: | CDR0000067835, AMC-020 |
Study First Received: | June 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005824 History of Changes |
Health Authority: | United States: Federal Government |
AIDS-related peripheral/systemic lymphoma AIDS-related diffuse large cell lymphoma AIDS-related immunoblastic large cell lymphoma AIDS-related small noncleaved cell lymphoma |
HIV-associated Hodgkin lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma AIDS-related lymphoblastic lymphoma |
Immunologic Factors Cyclophosphamide Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, AIDS-Related Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Alkylating Agents Hodgkin Disease Lymphoma Lymphoma, AIDS-related Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Acquired Immunodeficiency Syndrome Hodgkin's Disease Small Non-cleaved Cell Lymphoma Immunosuppressive Agents Recurrence Lymphatic Diseases B-cell Lymphomas HIV Infections Busulfan Primary Effusion Lymphoma Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions Lymphoma, B-Cell |
Lymphatic Diseases Neoplasms Lymphoma, AIDS-Related Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Alkylating Agents Lymphoma |