a safety and effectiveness study of vaccine therapy in patients with indolent lymphoma

Conditions: Lymphoma, Follicular; Lymphoma, Small Lymphocytic

Summary: primary objectives: * to document the efficacy of treatment with autologous lymphoma-derived hsppc-96 of selected patients with indolent lymphoma. the efficacy endpoints are: * the rate of complete and partial responses * the time to progression. secondary objectives: * to evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (hsppc-96) administered intradermally once weekly for four consecutive weeks, followed by hsppc-96 administered once every two weeks. * to evaluate the feasibility of autologous hsppc-96 preparation from lymphoma specimens. * to assess approximately the composition of the tissue source of the autologous hsppc-96 for each patient. * to study the effect of autologous lymphoma-derived hsppc-96 vaccine therapy on the expression of fas ligand and trail death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.


Eligibility criteria:
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.

Keywords: non-hodgkin's lymphoma brill-symmers disease follicular lymphoma lymphoma, giant follicular lymphoma, nodular follicular lymphoma, giant giant follicular lymphoma lymphocytic lymphoma, diffuse, well-differentiated lymphocytic lymphoma, well-differentiated lymphoma, lymphocytic, diffuse, well-differentiated lymphoma, lymphocytic, well-differentiated lymphoma, lymphoplasmacytoid, cll lymphoma, small lymphocytic, plasmacytoid lymphoplasmacytoid lymphoma, cll diffuse well-differentiated lymphocytic lymphoma lymphocytic lymphoma, diffuse, well differentiated lymphocytic lymphoma, well differentiated lymphoma, lymphocytic, diffuse, well differentiated lymphoma, lymphocytic, well differentiated lymphoma, mucosa-associated lymphoid tissue malt lymphoma lymphoma of mucosa-associated lymphoid tissue mucosa-associated lymphoid tissue lymphoma monocytoid b-cell lymphoma waldenstrom's macroglobulinemia marginal zone lymphoma