A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Aggressive B Cell Lymphoma

0197-99-FB

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.

1999-06-25

2002-01-01

2003-11-20

Completed

Early phase I

-1

Inclusion Criteria: * 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 * Over 18 years old * Karnofsky 80-100% * WBC greater than 2,500/mm3 * Platelet count greater than 100,000/mm3 * Hemoglobin at least 10 g/dL * Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 2 times normal * Creatinine less than 2.0 mg/dL * Fertile patients must use effective contraception during and for 6 months after the study * At least 2 months since prior nonphysiologic doses of prednisone of greater than 20 mg or equivalent * HIV negative Exclusion Criteria: * No CNS metastasis * 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 * Not pregnant or nursing/negative pregnancy test * No prior biologic therapy for lymphoma * No prior cytotoxic chemotherapy for lymphoma * No prior steroids for lymphoma * No concurrent maintenance steroids or greater than 5mg of daily prednisone or equivalent * No prior radiotherapy for lymphoma

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'primaryPurpose': 'TREATMENT'}}

2023-09-07