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

Sponsor
Favrille (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00036426
Collaborator
(none)
22
12
1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: FavId (Id-KLH) active immunotherapy
Phase 2

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 Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Mar 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Stevens Cancer Center La Jolla California United States 92037
    2 University of California San Diego La Jolla California United States 92093
    3 Tower Hematology Oncology Medical Group Los Angeles California United States 90048
    4 Oncology Associates of San Diego San Diego California United States 92123
    5 Medical Group of North County Vista California United States 92083
    6 University of Florida, Jacksonville Jacksonville Florida United States 32209
    7 Northwestern University Chicago Illinois United States 60611
    8 Henry Ford Hospital Detroit Michigan United States 48202
    9 New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center Bronx New York United States 10466
    10 New York Hospital - Cornell Medical Center New York New York United States 10021
    11 Oncology Hematology Care, Inc. Cincinnati Ohio United States 45219
    12 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111

    Sponsors and Collaborators

    • Favrille

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00036426
    Other Study ID Numbers:
    • FavId-01
    • NCT00014157
    First Posted:
    May 10, 2002
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Oct 1, 2004
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 24, 2005