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

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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Filgrastim Lenograstim Granulocyte colony-stimulating factor Rituximab

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Primary Effusion Lymphoma Lymphoma AIDS Related B-cell Lymphoma

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

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 to 99 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001563

Locations


United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Wyndham H Wilson, M.D.	National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dunleavy K, Little RF, Pittaluga S, Grant N, Wayne AS, Carrasquillo JA, Steinberg SM, Yarchoan R, Jaffe ES, Wilson WH. The role of tumor histogenesis, FDG-PET, and short-course EPOCH with dose-dense rituximab (SC-EPOCH-RR) in HIV-associated diffuse large B-cell lymphoma. Blood. 2010 Apr 15;115(15):3017-24. doi: 10.1182/blood-2009-11-253039. Epub 2010 Feb 3.


Responsible Party:	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:	August 31, 2016
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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell	Lymphoma, Non-Hodgkin Rituximab Lenograstim Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 30, 2016