- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005824
Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma
Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Maryland
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Baltimore, Maryland, United States, 21231
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02129
- Massachusetts General Hospital Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: David T. Scadden, MD, Massachusetts General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- AIDS-related peripheral/systemic lymphoma
- AIDS-related diffuse large cell lymphoma
- AIDS-related immunoblastic large cell lymphoma
- AIDS-related small noncleaved cell lymphoma
- AIDS-related diffuse mixed cell lymphoma
- AIDS-related diffuse small cleaved cell lymphoma
- AIDS-related lymphoblastic lymphoma
- HIV-associated Hodgkin lymphoma
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, AIDS-Related
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Busulfan
Other Study ID Numbers
- AMC-020
- CDR0000067835 (Other Identifier: NCI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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