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

Agenus

Status and phase

Completed

Phase 2

Conditions

Lymphoma, Follicular

Lymphoma, Small Lymphocytic

Treatments

Drug: autologous human tumor-derived HSPPC-96

Study type

Interventional

Funder types

Industry

Identifiers

NCT00081809

C-100-09

MDACC Protocol ID99-354

Details and patient eligibility

About

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.

Sex

All

Volunteers

No 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.