Trials / Completed
CompletedNCT00001563
EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma
EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Filgrastim | Filgrastim after EPOCH-R from Day 6 for 10 days every cycle. |
| BIOLOGICAL | Rituximab | EPOCH-R every 3 weeks for up to 6 cycle |
| DRUG | EPOCH | EPOCH-R every 3 weeks for up to 6 cycle |
Timeline
- Start date
- 1997-01-08
- Primary completion
- 2005-05-05
- Completion
- 2005-05-05
- First posted
- 1999-11-04
- Last updated
- 2022-01-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00001563. Inclusion in this directory is not an endorsement.