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

Sponsor

Agenus Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00081809

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Follicular Lymphoma, Small Lymphocytic	Drug: autologous human tumor-derived HSPPC-96	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2000

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.