Protocol Number: 01-C-0030

Title:

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

Number:

01-C-0030

Summary:

This study will evaluate the safety and effectiveness of a short course of chemotherapy to treat non-Hodgkin's lymphoma in patients with HIV infection. HIV-infected patients have a weakened immune system, and chemotherapy, which is used to treat lymphoma, further compromises immune function. This study will test whether reducing the total amount of chemotherapy using a specific combination of drugs will rid the body of lymphoma quickly, while decreasing the risk of infections and future cancers.

Patients with non-Hodgkin's lymphoma and HIV infection age 13 years and older who are not pregnant or nursing and who have not been treated previously with rituximab may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, and an electrocardiogram. Bone marrow aspiration and biopsy, lumbar puncture (spinal tap), and imaging tests such as magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET) and X-rays will also be done to determine the location and extent of the lymphoma.

Participants will receive chemotherapy on an outpatient basis for a period of 6 to 18 weeks in 3-week cycles as follows: prednisone by mouth on days 1 through 5; etoposide, doxorubicin and vincristine intravenously (through a vein) on days 1 through 5; and cyclophosphamide by intravenous injection on day 5. In addition, an antibody called rituximab, which attaches to lymphoma cells and may increase the effectiveness of the chemotherapy, will be given twice during each treatment cycle on days 1 and 5. Starting day 6, patients receive no chemotherapy for 16 days. They will, however, receive a drug called G-CSF for about 2 weeks, beginning day 6 of the cycle. G-CSF is a protein naturally produced by bone marrow that may boost immune function. The chemotherapy and rituximab are infused through a vein by means of a lightweight portable pump. Patients are taught how to use this pump, as well as how to give themselves G-CSF injections under the skin.

Patients will receive additional chemotherapy (methotrexate, leucovorin, cytosine arabinoside and rituximab) via lumbar puncture or an Ommaya-a device that is surgically placed in the head. This is necessary in order to treat lymphoma in the brain and spinal fluid-areas that intravenous drugs cannot reach. For the lumbar puncture, a small needle is inserted through the skin and muscle in the lower back, going between the bones of the spine until the needle punctures the spinal canal covering. If lumbar puncture is not feasible, an Ommaya may be used.

If evidence of lymphoma disappears quickly, treatment will be stopped after 2 or 3 cycles. In any case, patients will receive a maximum of 6 cycles. They will be followed periodically for 2 years with various tests, such as blood tests and imaging scans, to monitor disease progress.

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 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 Keywords:

None

Conditions:

AIDS Related Lymphoma

HIV Infection

Investigational Drug(s):

Rituximab

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:

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

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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