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

AIDS Related Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001563
• Other study ID #: 970040
• Secondary ID: 97-C-0040
• Status: Completed
• Phase: Phase 2
• Start date: January 8, 1997
• Est. completion date: May 5, 2005

Study information

• Verified date: January 2022
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00019253

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 5, 2005
• Est. primary completion date: May 5, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• AIDS Related Lymphoma
• AIDS-Associated Lymphoma
• Lymphoma
• Lymphoma, AIDS-Related

Intervention

Biological:
• Filgrastim
Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.
• Rituximab
EPOCH-R every 3 weeks for up to 6 cycle

Drug:
• EPOCH
EPOCH-R every 3 weeks for up to 6 cycle

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Beral V, Peterman T, Berkelman R, Jaffe H. AIDS-associated non-Hodgkin lymphoma. Lancet. 1991 Apr 6;337(8745):805-9. — View Citation

Kaplan LD, Abrams DI, Feigal E, McGrath M, Kahn J, Neville P, Ziegler J, Volberding PA. AIDS-associated non-Hodgkin's lymphoma in San Francisco. JAMA. 1989 Feb 3;261(5):719-24. — View Citation

Sparano JA, Wiernik PH, Strack M, Leaf A, Becker NH, Sarta C, Carney D, Elkind R, Shah M, Valentine ES, et al. Infusional cyclophosphamide, doxorubicin and etoposide in HIV-related non-Hodgkin's lymphoma: a follow-up report of a highly active regimen. Leuk Lymphoma. 1994 Jul;14(3-4):263-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of safety profile and response rates	number and types of adverse events {AEs), as well as the number of patients who respond to the therapy {CR, PR, SD)	End of Study

External Links

•   NIH Clinical Center Detailed Web Page