Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Cyclophosphamide Busulfan

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma Lymphoma, Large-cell Primary Effusion Lymphoma Diffuse Large B-Cell Lymphoma Lymphoblastic Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma AIDS Related B-cell Lymphoma

U.S. FDA Resources

Further study details as provided by AIDS Malignancy Consortium:


Study Start Date:	November 2000
Study Completion Date:	April 2006
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years to 120 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005824

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

Sponsors and Collaborators

AIDS Malignancy Consortium

National Cancer Institute (NCI)

Investigators


Study Chair:	David T. Scadden, MD	Massachusetts General Hospital

More Information

Publications:

Spitzer TR, Ambinder RF, Lee JY, Kaplan LD, Wachsman W, Straus DJ, Aboulafia DM, Scadden DT. Dose-reduced busulfan, cyclophosphamide, and autologous stem cell transplantation for human immunodeficiency virus-associated lymphoma: AIDS Malignancy Consortium study 020. Biol Blood Marrow Transplant. 2008 Jan;14(1):59-66.


ClinicalTrials.gov Identifier:	NCT00005824 History of Changes
Other Study ID Numbers:	AMC-020 CDR0000067835
Study First Received:	June 2, 2000
Last Updated:	February 1, 2016
Health Authority:	United States: Federal Government

Keywords provided by AIDS Malignancy 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 Cyclophosphamide	Busulfan Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists

ClinicalTrials.gov processed this record on September 29, 2016