Overview

EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection

Status:
Active, not recruiting
Trial end date:
2027-03-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Rituximab
Criteria
- 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