Protocol Number: 01-C-0030

Title:

Short-Course EPOCH-Rituximab for Untreated CD-20+ HIV-Associated Lymphomas

Number:

01-C-0030

Summary:

Background:

-HIV-infected patients have a weakened immune system, and chemotherapy, which is used to treat lymphoma, probably causes further damage to the immune system.

-Limiting the amount of immune damage due to chemotherapy might decrease the number of infections and the risk of developing cancer in the future in HIV-infected patients with non-Hodgkin's lymphoma.

Objectives:

-To determine whether reducing the total amount of chemotherapy using a specific combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing the risk of infections and future cancers.

-To determine whether the lymphoma will remain undetectable for at least one year if treatment is stopped one cycle after the patient enters remission.

Eligibility:

-Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy.

Design:

-Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles.

-The lymphoma is evaluated using CT and PET scans at the end of treatment cycles 2 and 3. A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on screening for participation in the study.

-Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R treatment ends.

-Patients are monitored for treatment response with blood tests and imaging scans at baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6 months for a total of 24 months following chemotherapy.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Aggressive CD20 positive NHL confirmed by Pathology, DCS.

HIV + serology.

All stages (I-IV) of disease.

ECOG Performance status 0-4

NHL previously untreated with cytotoxic chemotherapy.

Age greater than or equal to 4 years

Laboratory tests (unless impairment due to respective organ involvement by tumor):

-Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min

Pediatric patients: Age-adjusted normal serum creatinine according to the following table or a creatinine clearance greater than 60 ml/min/1.73 m(2).

Less than or equal to 5 age (years), 0.8 Maximum serum creatinine

Greater than 5, less than or equal to 10 age (years), 1.0 Maximum serum creatinine

Greater than 10, less than or equal to 15 age (years), 1.2 Maximum serum creatinine

Greater than 15 age (years), 1.5 Maximum serum creatinine

-Bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with direct fraction less than or equal to 0.3 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 3x ULN (AST and ALT less than or equal to 6x ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation)

-ANC greater than or equal to 1000/mm(3)

-Platelet greater than or equal to 75,000/mm(3) (unless impairment due to ITP)

Ability of patient or parent/guardian to provide informed consent.

EXCLUSION CRITERIA:

Previous rituximab

Pregnancy or nursing.

- Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk.

- Antiretroviral therapy is indicated during pregnancy and nursing.

Current clinical heart failure or symptomatic ischemic heart disease.

Serious underlying medical condition or infection other than HIV that would contraindicate SC-EPOCH-R.

- Examples include, but are not limited to:

- Severe AIDS-related wasting

- Sever intractable diarrhea

- Active inadequately treated opportunistic infection of the CNS

Concurrent anti-retroviral therapy during EPOCH therapy.

Primary CNS lymphoma.

Adolescents who do not freely assent

Special Instructions:

Currently Not Provided

Keywords:

AIDS

Malignancy

Antiretroviral

Chemotherapy

Monoclonal

Recruitment Keyword(s):

None

Condition(s):

AIDS Related Lymphoma

HIV Infection

Investigational Drug(s):

Rituximab

Investigational Device(s):

None

Intervention(s):

Drug: Rituximab

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Low-dose compared with standard-dose m-BACOD chemotherapy for non-Hodgkin's lymphoma associated with human immunodeficiency virus infection National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group

Clinical evaluation of 451 patients with HIV related non-Hodgkin's lymphoma: experience on the Italian cooperative group on AIDS and tumors (GICAT)

Epidemiology, clinical characteristics, and management of AIDS-related lymphoma

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