This study is NOT currently recruiting participants.
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)
Investigational Device(s)
Intervention(s)
Biological/Vaccine: Rituximab Biological/Vaccine: Filgrastim Drug: EPOCH
Supporting Site
National Cancer Institute
-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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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
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
Principal Investigator
Referral Contact
For more information: