A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)

Date de début de l'étude : 1 mars 2000

Inclusion Criteria: * Patients with previously treated or newly diagnosed follicular center cell grade I or grade II lymphoma, small lymphocytic lymphoma, MALT lymphoma, monocytoid B-cell lymphoma, Waldenstrom's macroglobulinemia, or marginal zone lymphoma with bidimensionally measurable disease; * Part of the resected specimen must undergo routine pathologic examination to confirm the diagnosis of lymphoma. The remaining tissue must be used for the preparation of autologous HSPPC-96; * Autologous HSPPC-96 vaccine must be successfully prepared and provided by the sponsor; * A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96 preparation; * Bidimensionally measurable disease in at least one location other than the resected lymphoid tissue; * Life expectancy of at least 16 weeks; * Zubrod performance status of less then or equal to 2; * Adequate bone marrow function; * Adequate hepatic function; * Adequate renal function; * Signed written informed consent; * Patients of child-bearing potential must practice contraception, which is adequate in the opinion of the Principal Investigator; * Patients of child-bearing potential must have a negative serum pregnancy test prior to entry into the study and must not be lactating; * Patients must be willing to be followed at the M. D. Anderson Cancer Center during the course of treatment and follow-up; * Electrocardiogram if none performed in the prior six months; * Patients must have no chemotherapy, immunotherapy, radiotherapy, or experimental anti-cancer therapy within six weeks prior to starting autologous HSPPC-96 administration; * Patients must have fully recovered from prior anti-cancer therapy; * Tumor measurements and staging no more than 4 weeks prior to receiving the first dose of autologous HSPPC-96. Exclusion Criteria: * Patients with active or prior history of central nervous system lymphoma; * Patients with serious intercurrent medical illnesses, requiring hospitalization; * Patients with a history of primary or secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on functional immune system) or patients taking immunosuppressive drugs such as systemic corticosteroids; * Women who are pregnant or lactating; * Patients participating in another clinical trial; * Patients receiving growth factors of any kind, including G-CSF, GM-CSF, or Epogen; * Patients with bulky disease, defined as greater than 10 cm in diameter; * Patients with positive HIV antibody; * Patients with more than 4 previous treatment regimens will be excluded.