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

Lymphoma, Low-Grade Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00036426
• Other study ID #: FavId-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 9, 2002
• Last updated: June 23, 2005
• Start date: March 2001

Study information

• Verified date: October 2004
• Source: Favrille
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00014157

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Low-Grade
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• FavId (Id-KLH) active immunotherapy

Locations

Country	Name	City	State
United States	New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center	Bronx	New York
United States	Northwestern University	Chicago	Illinois
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Florida, Jacksonville	Jacksonville	Florida
United States	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	New York Hospital - Cornell Medical Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Oncology Associates of San Diego	San Diego	California
United States	Medical Group of North County	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Favrille

Country where clinical trial is conducted

United States,