Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have previously untreated HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus monoclonal antibody therapy is more effective than combination chemotherapy alone in treating HIV-associated non-Hodgkin's lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven HIV-associated B cell non-Hodgkin's lymphoma, including:

• Diffuse large B cell lymphoma

• Intermediate grade diffuse large cell lymphoma

• High grade large cell immunoblastic lymphoma

• Burkitt's lymphoma

• High grade B cell lymphoma, Burkitt's like (small noncleaved lymphoma)

• No primary CNS lymphoma (parenchymal brain or spinal cord tumor)

• Evaluable disease HIV documentation may be serologic (ELISA or western blot), culture, or quantitative PCR or bDNA assay Tumors must be CD20 positive (greater than 50% cells express CD20)

• A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

• Age: Over 18

• Performance status: Karnofsky 70-100%

• Absolute neutrophil count greater than 1,000/mm3*

• Platelet count greater than 75,000/mm3*

• Unless cytopenias are secondary to lymphoma

• Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of indinavir)

• SGOT or SGPT less than 7 times upper limit of normal

• Creatinine less than 2.0 mg/dL (unless due to lymphoma)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No acute, active HIV-associated opportunistic infection requiring antibiotics

• Mycobacterium avium complex allowed

• No concurrent malignancy except carcinoma in situ of the cervix, nonmetastatic nonmelanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy

PRIOR CONCURRENT THERAPY:

• Prior or concurrent epoetin alfa or filgrastim (G-CSF) allowed

• No prior colony stimulating factor therapy within 24 hours prior to chemotherapy

• No prior chemotherapy for HIV-associated non-Hodgkin's lymphoma

• At least 1 year since prior cyclophosphamide or doxorubicin

• No prior radiotherapy for HIV-associated non-Hodgkin's lymphoma

• Chronic therapy with myelosuppressive agents allowed

• Concurrent antiretroviral therapy, antifungal medications, and antibiotics allowed