EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
AIDS Related Lymphoma |
Biological: Filgrastim Biological: Rituximab Drug: EPOCH |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma |
- Determination of safety profile and response rates [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
| Enrollment: | 39 |
| Study Start Date: | December 1996 |
| Study Completion Date: | May 2005 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
EPOCH-R every 3 weeks for up to 6 cycle
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00001563
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Wyndham H Wilson, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) |
| ClinicalTrials.gov Identifier: | NCT00001563 History of Changes |
| Obsolete Identifiers: | NCT00019253 |
| Other Study ID Numbers: | 970040, 97-C-0040 |
| Study First Received: | November 3, 1999 |
| Last Updated: | September 6, 2014 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Lymphomagenesis Molecular markers of drug resistance Refractory, progressive, or relapsed HIV + NHL AIDS-related NHL |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, AIDS-Related Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms |
Neoplasms by Histologic Type Rituximab Antineoplastic Agents Antirheumatic Agents Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2015