Interleukin-12 Following Chemotherapy in Treating Patients With Refractory HIV-Associated Non-Hodgkin's Lymphoma

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

Summary

Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in treating patients who have refractory HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person' white blood cells to kill cancer cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Etoposide; Etoposide phosphate; Ifosfamide; Interleukin-12; Isophosphamide mustard; Lenograstim

Criteria

DISEASE CHARACTERISTICS:

• HIV-infected patients with histologically or cytologically proven intermediate grade large cell lymphoma; high grade large cell immunoblastic lymphoma; or high grade small noncleaved cell lymphoma who have either failed to respond to or relapsed following first line combination chemotherapy

• Bidimensionally measurable disease

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

• No meningeal lymphoma

• 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: 18 to 70

• Performance status: Karnofsky 60-100%

• Absolute neutrophil count at least 1,000/mm3

• Platelet count greater than 75,000/mm3

• Hematologic criteria not applicable if abnormal functions are attributable to lymphomatous infiltration of bone marrow or liver

• Bilirubin less than 2.0 mg/dL, except in patients receiving indinavir who have isolated hyperbilirubinemia

• Transaminases less than 5 times upper limit of normal

• Hepatic criteria not applicable if abnormal functions are attributable to lymphomatous infiltration of bone marrow or liver

• Creatinine clearance greater than 60 mL/min

• No other prior or concurrent malignancy except carcinoma in situ of the cervix or nonmetastatic nonmelanomatous skin cancer

• No acute active opportunistic infection requiring antibiotic treatment Patients with Mycobacterium avium complex allowed

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior immunomodulating agents

• Concurrent filgrastim (G-CSF) allowed

• Concurrent epoetin alfa allowed

• Concurrent antibiotics may be given if clinically indicated during study

• No more than 2 prior standard treatment regimens for non-Hodgkin's lymphoma

• No concurrent systemic corticosteroids

• Concurrent topical and/or oral antifungal agents permitted