NCT00081809

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (planned)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Follicular
• Lymphoma, Small Lymphocytic

Interventions

Type	Name	Description
DRUG	autologous human tumor-derived HSPPC-96

Timeline

• Start date: 2000-03-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2004-04-23
• Last updated: 2023-09-28

Locations

1 site across 1 country: United States