Status:
COMPLETED
A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
Lead Sponsor:
Agenus Inc.
Conditions:
Lymphoma, Follicular
Lymphoma, Small Lymphocytic
Eligibility:
All Genders
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00081809
Start Date
March 1 2000
End Date
June 1 2005
Last Update
September 28 2023
Active Locations (1)
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1
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030