Status:

COMPLETED

A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Schering-Plough

Conditions:

Lymphoma, Non-Hodgkin

HIV Infections

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing inter...

Detailed Description

HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effect...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Required:

  • PCP prophylaxis with Bactrim, aerosolized pentamidine, or dapsone.

Allowed:

ddI, except when patient is also taking allopurinol.

Patients must have the following:

  • Diagnosis of HIV seropositivity and non-Hodgkin's lymphoma.
  • Ability to give informed consent and willingness to comply with all procedures and visit schedule.
  • If between ages of 12 and 18 must receive care under direct supervision of a pediatric oncologist, and have consent of parent, guardian, or person with power of attorney.
  • Participation in clinical trials of other antiretroviral agents is at the discretion of the investigator and individual patient.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Active opportunistic infection, excluding Mycobacterium avium complex, requiring antibiotic therapy.
  • Another prior or current malignancy, excepting curatively treated cervical or basal cell carcinoma.
  • Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing peripheral edema.
  • Primary central nervous system lymphoma.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT) or any antiretroviral agent unless allowed by investigator. ddI is allowed except when also taking allopurinol.

Systemic myelosuppressive drugs, including trimethoprim/sulfamethoxazole (T/S), pyrimethamine/sulfa, or ganciclovir.

-

Patients with the following are excluded:

  • Active opportunistic infection, excluding Mycobacterium avium complex, requiring antibiotic therapy.
  • Another prior or current malignancy, excepting curatively treated cervical or basal cell carcinoma.
  • Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing peripheral edema.
  • Primary central nervous system lymphoma.

Prior Medication:

Excluded:

  • Immunomodulating agents within 2 weeks of study entry.

Prior Treatment:

Excluded:

  • Chemotherapy.

Radiation therapy as outlined in protocol.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

February 1 1996

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT00000658

End Date

February 1 1996

Last Update

November 3 2021

Active Locations (22)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 6 (22 locations)

1

USC CRS

Los Angeles, California, United States, 900331079

2

UCLA CARE Center CRS

Los Angeles, California, United States, 90095

3

Ucsf Aids Crs

San Francisco, California, United States, 941102859

4

University of Colorado Hospital CRS

Aurora, Colorado, United States, 80262

A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma | DecenTrialz