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

NCT ID: NCT00036426

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31

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.

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.

Conditions

Lymphoma, Low-Grade

Keywords

lymphoma; vaccine; idiotype; KLH; GM-CSF

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

FavId (Id-KLH) active immunotherapy

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Favrille

INDUSTRY

Sponsor Role: lead

Locations

Scripps Stevens Cancer Center

La Jolla, California, United States

University of California San Diego

La Jolla, California, United States

Tower Hematology Oncology Medical Group

Los Angeles, California, United States

Oncology Associates of San Diego

San Diego, California, United States

Medical Group of North County

Vista, California, United States

University of Florida, Jacksonville

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Henry Ford Hospital

Detroit, Michigan, United States

New York Hospital - Cornell Medical Center

New York, New York, United States

New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center

The Bronx, New York, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

FavId-01

Identifier Type: -

Identifier Source: org_study_id

NCT00014157

Identifier Type: -

Identifier Source: nct_alias