Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma
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Purpose
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 |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Procedure: peripheral blood stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the safety and tolerability of intensive chemotherapy and autologous peripheral blood stem cell transplantation in patients with recurrent or refractory AIDS-related lymphoma.
- Determine the response and response duration in these patients treated with this regimen.
- Determine the effect of this treatment regimen on HIV RNA and CD4 cells in these patients.
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.
Eligibility| 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
- Failed to achieve complete remission with initial therapy OR
- Relapsed after initial therapy
- May be in complete remission after salvage therapy
Sensitive to most recent chemotherapy
- Improvement of at least 25% in bidimensional tumor measurements OR
- Improvement in evaluable disease sustained over 4 weeks
- Measurable or evaluable disease
- HIV-1 positive
- CD4 greater than 50 cells/mm^3 (unless not receiving optimal antiretroviral therapy)
- HIV RNA less than 110,000 copies/mL (unless not receiving optimal antiretroviral therapy)
- No active leptomeningeal or parenchymal CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- Physiologic 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
Hepatic:
- AST no greater than 3 times upper limit of normal
- Bilirubin no greater than 2.0 mg/dL (unless receiving indinavir)
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No history of cardiac disease
- LVEF at least 45%
Pulmonary:
- No history of symptomatic pulmonary disease
- DLCO at least 60%
Other:
- No active opportunistic infections
- No cytomegalovirus retinitis or pneumonitis requiring maintenance therapy
- No sensitivity to E. coli-derived products
- Not pregnant
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 1 week since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- Chronic suppressive therapy for infection allowed
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00005824 History of Changes |
| Other Study ID Numbers: | CDR0000067835, AMC-020 |
| Study First Received: | June 2, 2000 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by AIDS Malignancy Clinical Trials Consortium:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, AIDS-Related Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Busulfan Cyclophosphamide Lenograstim |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antirheumatic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 23, 2013