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

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ClinicalTrials.gov Identifier: NCT00005824
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
AIDS Malignancy Consortium

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Procedure: peripheral blood stem cell transplantation Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Masking: None (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
Actual Primary Completion Date : July 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

ClinicalTrials.gov Identifier: NCT00005824     History of Changes
Other Study ID Numbers: AMC-020
CDR0000067835 ( Other Identifier: NCI )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016

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