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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

David T. Scadden, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067835

NCT ID:

NCT00005824

Start Date:

November 2000

Completion Date:

April 2006

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, AIDS-Related

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410