EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-08

Study Completion Date

2005-05-05

Brief Summary

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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.

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Detailed Description

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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

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AIDS Related Lymphoma AIDS-Associated Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

EPOCH-R every 3 weeks for up to 6 cycle

Group Type EXPERIMENTAL

Filgrastim

Intervention Type BIOLOGICAL

Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.

Rituximab

Intervention Type BIOLOGICAL

EPOCH-R every 3 weeks for up to 6 cycle

EPOCH

Intervention Type DRUG

EPOCH-R every 3 weeks for up to 6 cycle

Interventions

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Filgrastim

Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.

Intervention Type BIOLOGICAL

Rituximab

EPOCH-R every 3 weeks for up to 6 cycle

Intervention Type BIOLOGICAL

EPOCH

EPOCH-R every 3 weeks for up to 6 cycle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No