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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2004 by Favrille.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Favrille
ClinicalTrials.gov Identifier:
NCT00036426
First received: May 9, 2002
Last updated: June 23, 2005
Last verified: October 2004
  Purpose

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 Intervention Phase
Lymphoma, Low-Grade
Biological: FavId (Id-KLH) active immunotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Favrille:

Estimated Enrollment: 22
Study Start Date: March 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036426

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

No publications provided

ClinicalTrials.gov Identifier: NCT00036426     History of Changes
Obsolete Identifiers: NCT00014157
Other Study ID Numbers: FavId-01
Study First Received: May 9, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Favrille:
lymphoma
vaccine
idiotype
KLH
GM-CSF

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 20, 2014