A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
- Conditions
- Lymphoma, FollicularLymphoma, Small Lymphocytic
- Registration Number
- NCT00081809
- Lead Sponsor
- Agenus Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States