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)
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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