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Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma
This study has been completed.
First Received: June 2, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: AIDS Associated Malignancies Clinical Trials Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005824
  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 II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Cyclophosphamide Busulfan Filgrastim
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
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 Associated Malignancies Clinical Trials Consortium
Investigators
Study Chair: David T. Scadden, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067835, AMC-020
Study First Received: June 2, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005824     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Immunologic Factors
Cyclophosphamide
Lymphoblastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, AIDS-Related
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-cell
Alkylating Agents
Hodgkin Disease
Lymphoma
Lymphoma, AIDS-related
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Acquired Immunodeficiency Syndrome
Hodgkin's Disease
Small Non-cleaved Cell Lymphoma
Immunosuppressive Agents
Recurrence
Lymphatic Diseases
B-cell Lymphomas
HIV Infections
Busulfan
Primary Effusion Lymphoma
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Immunosuppressive Agents
Pharmacologic Actions
Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Lymphoma, AIDS-Related
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Alkylating Agents
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009