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

NCT00081809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-09-28

No results posted yet for this study

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

DRUG

autologous human tumor-derived HSPPC-96

Sponsors & Collaborators

  • Agenus Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00081809 on ClinicalTrials.gov