Lymphoma, Follicular, Lymphoma, Small Lymphocytic
Conditions
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
Brief 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.
Interventions
Sponsors
Agenus Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed