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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00005824
First received: June 2, 2000
Last updated: January 22, 2013
Last verified: January 2013
  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:


Further study details as provided by AIDS Malignancy Clinical Trials 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 and older
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
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 Clinical Trials Consortium
Investigators
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 April 23, 2014