AIDS Related Lymphoma, AIDS-Associated Lymphoma
Conditions
Keywords
Lymphomagenesis, Molecular markers of drug resistance, Refractory, progressive, or relapsed HIV + NHL, AIDS-related NHL
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 dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.
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 dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.
Interventions
BIOLOGICALFilgrastim
Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.
BIOLOGICALRituximab
EPOCH-R every 3 weeks for up to 6 cycle
DRUGEPOCH
EPOCH-R every 3 weeks for up to 6 cycle
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of safety profile and response rates | End of Study | number and types of adverse events {AEs), as well as the number of patients who respond to the therapy {CR, PR, SD) |
Countries
United States
Outcome results
None listed