Status:
COMPLETED
EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
AIDS Related Lymphoma
AIDS-Associated Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported disma...
Detailed Description
The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported disma...
Eligibility Criteria
- INCLUSION CRITERIA:
Aggressive CD20 + NHL confirmed by Pathology, DCS.
HIV + serology.
All stages (I-IV) of disease.
NHL previously treated with up to two chemotherapy regimens and evaluable disease.
Age greater than or equal to 18 years.
Laboratory test: (Abnormalities are allowed if due to organ involvement by lymphoma).
Creatinine less than or equal to 1.7.
Bilirubin must be less than 2.0 mg/dl, or total bilirubin less than or equal to 3.7 mg/dl with direct fraction less than or equal to 0.2 mg/dl and indirect fraction of less than or equal 3.5 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy.
AST and ALT less than or equal to 3 times ULN (AST and ALT less than or equal to 6 times ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation).
ANC greater than or equal 1000/mm(3).
Platelets must be greater than or equal to 75,000/mm(3) (patients with ITP platelets greater than or equal to 30,000/mm(3).
Signed informed consent and Durable Power of Attorney.
EXCLUSION CRITERIA:
Pregnancy or nursing.
History of clinical heart failure or symptomatic ischemic heart disease.
Serious underlying medical condition or infection other than HIV that would contraindicate EPOCH.
Concurrent anti-retroviral therapy during EPOCH therapy.
Primary CNS lymphoma.
Key Trial Info
Start Date :
January 8 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2005
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00001563
Start Date
January 8 1997
End Date
May 5 2005
Last Update
January 19 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892