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Completed

NCT Number: NCT00005824

Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory 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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

busulfan

Drug

Cyclophosphamide

Drug

peripheral blood stem cell transplantation

Procedure

Sponsors and collaborators

Lead sponsor

AIDS Malignancy Consortium

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma

Important dates

Study start
2000
Primary completion
2004
Study completion
2006
First posted
Jan 27, 2003
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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