A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymphoma, Follicular, Lymphoma, Small Lymphocytic

Intervention / Treatment
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* Drug: autologous human tumor-derived HSPPC-96


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: autologous human tumor-derived HSPPC-96|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, 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