Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma

June 23, 2005 updated by: Favrille

Phase II Study of FavId (Tumor-Specific Idiotype-KLH) and Soluble GM-CSF Immunotherapy in Patients With Stable or Progressive Grade 1 and 2 Follicular B-Cell Lymphomas

The purpose of this study was to determine if an idiotype vaccine, made from a patient's lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their tumor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study was to assess the ability of active immunotherapy to induce tumor regressions in relapsed low-grade lymphoma. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in the production of immunoglobulin idiotype. B-cell lymphomas arise from the clonal expansion of a single B-cell and all tumor cells express that unique Id protein. No normal B-cells possess that Id on their cell surface. Hence, Id protein should serve as an ideal target for individualized active immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak immunogens. To augment the immune response against Id, the Id protein must be chemically coupled to a strongly immunogenic protein. Keyhole limpet hemocyanin (KLH) is a commonly used protein carrier capable of augmenting the body's immune reaction against Id protein. While initial studies reported a predominately humoral (antibody) response, cellular immunity (T-cells) also plays a critical role in anti-tumor immunity. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation.

Study Type

Interventional

Enrollment

22

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
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • La Jolla, California, United States, 92037
        • Scripps Stevens Cancer Center
      • Los Angeles, California, United States, 90048
        • Tower Hematology Oncology Medical Group
      • San Diego, California, United States, 92123
        • Oncology Associates of San Diego
      • Vista, California, United States, 92083
        • Medical Group of North County
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida, Jacksonville
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New York
      • Bronx, New York, United States, 10466
        • New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
      • New York, New York, United States, 10021
        • New York Hospital - Cornell Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Oncology Hematology Care, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 18 years of age
  • Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)
  • Patients that have responded with at least stable disease to their most recent chemo- or anti-CD20 antibody (Rituxan®, Zevalin, Bexxar) therapy for a minimum of 90 days and who currently have relapsed or who continue to have stable disease.
  • Tumor accessible for biopsy or previously existing biopsy material
  • At least 1 additional bidimensional lesion measuring at least 2 cm in each dimension
  • Performance status (ECOG) of 0, 1 or 2
  • Absolute Granulocyte count ? 1,000/mm3
  • Total Bilirubin < 2 mg/dL
  • AST and ALT < 2x Upper Limit of Normal
  • Creatinine < 1.5 mg/dL

Exclusion Criteria

  • Patients who have had more than 3 prior chemotherapy or anti-CD20 regimens
  • Prior fludarabine
  • Prior tumor-specific idiotype immunotherapy
  • Patients whose disease has progressed within the first 90 days of their last chemotherapy or anti-CD20 treatment
  • Concurrent immunosuppressive therapy (high-dose steroids; etc)
  • Prior splenectomy
  • Surgery, cancer radiotherapy, steroid therapy, immunotherapy or chemotherapy within 90 days prior to first scheduled vaccination
  • Known history of CNS lymphoma or meningeal lymphomatosis
  • HIV positive
  • Serious non-malignant disease (e.g., psychiatric disorders, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives
  • Prior malignancy (excluding nonmelanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for > 2 years
  • Treatment with an investigational drug within 30 days prior to study entry
  • Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with FavId.

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

Favrille

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, 2001

Study Registration Dates

First Submitted

May 9, 2002

First Submitted That Met QC Criteria

May 9, 2002

First Posted (Estimate)

May 10, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FavId-01

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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