Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial of vaccine therapy plus sargramostim following chemotherapy in treating patients who have previously untreated aggressive non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: University of Nebraska
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Keyhole-limpet hemocyanin; Liposomal doxorubicin; Mitoxantrone; Prednisone; Sargramostim; Vaccines; Vincristine

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed aggressive non-Hodgkin's lymphoma Diffuse mixed cell Diffuse large cell Immunoblastic Follicular large cell with more than 50% large cells Mantle cell Non-age adjusted International Prognostic Index 2-4 Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy Must have adequate circulating lymphoma cells No CNS metastasis

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: WBC greater than 2,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Other: No other illness or condition, including innate or pharmacologic immunosuppression, that would preclude study No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after the study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for lymphoma Chemotherapy: No prior cytotoxic chemotherapy for lymphoma Endocrine therapy: No prior steroids for lymphoma At least 2 months since prior nonphysiologic doses of prednisone of greater than 20 mg or equivalent No concurrent maintenance steroids or greater than 5mg of daily prednisone or equivalent Radiotherapy: No prior radiotherapy for lymphoma Surgery: Not specified