Clinical Trial: Interleukin-12 Following Chemotherapy in Treating Patients With Refractory HIV-Associated Non-Hodgkin's Lymphoma

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
AIDS Associated Malignancies Clinical Trials Consortium
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person' white blood cells to kill cancer cells. PURPOSE: Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in treating patients who have refractory HIV-associated non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
AIDS-related small noncleaved cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
 Drug: etoposide
 Drug: filgrastim
 Drug: ifosfamide
 Drug: interleukin-12
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Interleukin-12 Following Response to Ifosfamide/Etoposide Chemotherapy in Patients with Refractory HIV-Associated Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: January 1999

OBJECTIVES: I. Determine the efficacy of interleukin-12 (IL-12) by evaluating its effect on remission duration after response to second line chemotherapy with ifosfamide and etoposide in patients with HIV-associated non-Hodgkin's lymphoma. II. Determine the safety of IL-12 when administered as maintenance therapy in these patients. III. Evaluate overall survival of this patient population. IV. Evaluate serum and tissue cytokine levels in these patients. V. Evaluate the effect of IL-12 on HIV viral load and on functional T-cell assays in these patients. VI. Evaluate the effect of IL-12 on Epstein-Barr Virus (EBV) viral load in these patients.

PROTOCOL OUTLINE: This is an open label study. All patients receive ifosfamide IV by continuous infusion for 2 days, etoposide IV over 2 hours daily on days 1 and 2, and filgrastim (G-CSF) subcutaneously (SC) daily on days 4-13. Courses are repeated every 21 days. Patients who have complete or partial remission after a minimum of 4 courses of chemotherapy receive maintenance therapy consisting of interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and continuing for 6 months or until disease progression. All patients also receive combination antiretroviral therapy during study. Patients are followed every month for one year, then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study to ensure that 15 patients will go on maintenance therapy.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[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.]

--Prior/Concurrent Therapy--

  • Biologic therapy: At least 2 weeks since prior immunomodulating agents; Concurrent filgrastim (G-CSF) allowed; Concurrent epoetin alfa allowed; Concurrent antibiotics may be given if clinically indicated during study
  • Chemotherapy: See Disease Characteristics; No more than 2 prior standard treatment regimens for non-Hodgkin's lymphoma
  • Endocrine therapy: No concurrent systemic corticosteroids
  • Radiotherapy: Not specified
  • Surgery: Not specified
  • Other: Concurrent topical and/or oral antifungal agents permitted

--Patient Characteristics--


Location Information


California
      San Francisco General Hospital Medical Center, San Francisco,  California,  94110,  United States

      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States

Florida
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States

Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114-2617,  United States

New Jersey
      University Hospital/New Jersey Cancer Center, Newark,  New Jersey,  07103,  United States

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      Mount Sinai School of Medicine, New York,  New York,  10029,  United States

      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States

Study chairs or principal investigators

Lawrence D. Kaplan,  Study Chair,  AIDS Associated Malignancies Clinical Trials Consortium   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066642; AMC-008
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003575
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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