NIH Clinical Research Studies

Protocol Number: 97-C-0040

Active Accrual, Protocols Recruiting New Patients

Title:
EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients with AIDS-Associated Lymphoma
Number:
97-C-0040
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.
Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility 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.

Special Instructions:
Many protocols are potentially hazardous, are intended only for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board.
Keywords:
HIV Lymphoma
Interleukin-12
Cytokines
Immunomodulation
Therapy
Recruitment Keywords:
None
Conditions:
AIDS Related Lymphoma
Non Hodgkin's Lymphoma
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239
Electronic Address: ncicssc@mail.nih.gov

Citations:
AIDS-associated non-Hodgkin's lymphoma in San Francisco

Infusional cyclophosphamide, doxorubicin and etoposide in HIV-related non-Hodgkin's lymphoma: a follow-up report of a highly active regimen

AIDS-associated non-Hodgkin lymphoma

Active Accrual, Protocols Recruiting New Patients

If you have:


Command Menu Bar

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home


Clinical Center LogoWarren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/19/2004

Search The Studies Help Questions