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

September 26, 2023 updated by: Agenus Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agenus Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

April 20, 2004

First Submitted That Met QC Criteria

April 22, 2004

First Posted (Estimated)

April 23, 2004

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-100-09
  • MDACC Protocol ID99-354

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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