Expired Study
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Houston, Texas 77030


Purpose:

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.


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.


NCT ID:

NCT00081809


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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