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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001563

Collaborator

(none)

Enrollment

Location

Arm

99.8

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AIDS Related Lymphoma AIDS-Associated Lymphoma	Biological: Filgrastim Biological: Rituximab Drug: EPOCH	Phase 2

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma

Actual Study Start Date :

Jan 8, 1997

Actual Primary Completion Date :

May 5, 2005

Actual Study Completion Date :

May 5, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.