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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005824
• Other study ID #: AMC-020
• Secondary ID: CDR0000067835
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: February 1, 2016
• Start date: November 2000
• Est. completion date: April 2006

Study information

• Verified date: February 2016
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2006
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, AIDS-Related

Intervention

Biological:
• filgrastim

Drug:
• busulfan

• cyclophosphamide

Procedure:
• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spitzer TR, Ambinder RF, Lee JY, Kaplan LD, Wachsman W, Straus DJ, Aboulafia DM, Scadden DT. Dose-reduced busulfan, cyclophosphamide, and autologous stem cell transplantation for human immunodeficiency virus-associated lymphoma: AIDS Malignancy Consortium — View Citation