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
OBJECTIVES: I. Determine the ability of recombinant idiotype immunotherapy to stimulate a
specific immune response against the B cell idiotype of the malignant clone that constitutes
the tumor in patients with previously untreated aggressive non-Hodgkin's lymphoma. II.
Determine the safety and toxicity of this treatment regimen using Genitope Corporation's
molecular rescue technology in this patient population.
OUTLINE: Patients receive induction chemotherapy consisting of cyclophosphamide,
doxorubicin, vincristine, and prednisone (CHOP) or cyclophosphamide, mitoxantrone,
vincristine, and prednisone (CNOP). Treatment repeats every 3 weeks until the maximal
clinical response is achieved followed by 2 additional courses of consolidation therapy for
up to a maximum of 6 courses. At 2-6 months following completion of chemotherapy, patients
achieving adequate disease response receive vaccination consisting of recombinant tumor
derived immunoglobulin idiotype with keyhole limpet hemocyanin conjugate subcutaneously (SQ)
followed by sargramostim (GM-CSF) SQ, each at 2 separate sites on day 1. Patients receive
GM-CSF alone on days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 3 months
later by the fifth and final dose. Patients are followed every 3 months for 2 years, every 6
months for 2 years, and then annually thereafter until disease progression.
PROJECTED ACCRUAL: Not specified
Primary Purpose: Treatment
Julie M. Vose, MD
University of Nebraska
United States: Federal Government
|Stanford University Medical Center||Stanford, California 94305-5408|
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|