drugset / Trial / NCT00081809

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

NCT00081809

Phase 2 Completed 35 enrolled Agenus Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2000-03
Primary completion
2005-06
Completion
2005-06

Drugs

EvaluationDrugModalityDoseRoute
Subject vitespen Vaccine Other