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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

01-C-0030

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Fetuses;
Pregnant Women

Keywords

AIDS;
Malignancy;
Antiretroviral;
Chemotherapy;
Monoclonal

Recruitment Keyword(s)

None

Condition(s)

lymphoma, AIDS-related;
Lymphoma, Large B-Cell, Diffuse

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: Rituximab
Biological/Vaccine: Filgrastim
Drug: EPOCH

Supporting Site

National Cancer Institute

Background:

-Human immunodeficiency virus (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 computed tomography (CT) and positron emission tomography (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.

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Eligibility

INCLUSION CRITERIA:

Aggressive CD20 positive Diffuse Large B-cell lymphoma confirmed by Laboratory of Pathology, NCI. Note: Participants with aggressive B-cell lymphoma of the plasmablastic lymphoma sub-type who do not have surface CD20 expression, are also eligible.

HIV + serology.

All stages (I-IV) of disease.

ECOG Performance status 0-4

NHL previously untreated with cytotoxic chemotherapy; however, participants may be entered if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexte (MTX) at the time of the pre-treatment diagnostic lumbar puncture

Age greater than or equal to 18 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

-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 participants 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 participants 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 participant to provide informed consent.

EXCLUSION CRITERIA:

Previous rituximab

Pregnancy or nursing.

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

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

- Primary CNS lymphoma

Primary CNS lymphoma


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mark J. Roschewski, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 12C442
10 CENTER DR
BETHESDA MD 20892
(240) 760-6183
mark.roschewski@nih.gov

Michael Emanuel, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4-3140
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6162
michael.emanuel@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT00006436

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