Non Hodgkin Lymphoma Clinical Trial
A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
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.
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There is 1 Location for this study
Houston Texas, 77030, United States
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