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

Primary Purpose

Lymphoma, Low-Grade

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FavId (Id-KLH) active immunotherapy
Sponsored by
Favrille
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Low-Grade focused on measuring lymphoma, vaccine, idiotype, KLH, GM-CSF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps Stevens Cancer Center
  • University of California San Diego
  • Tower Hematology Oncology Medical Group
  • Oncology Associates of San Diego
  • Medical Group of North County
  • University of Florida, Jacksonville
  • Northwestern University
  • Henry Ford Hospital
  • New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
  • New York Hospital - Cornell Medical Center
  • Oncology Hematology Care, Inc.
  • Fox Chase Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 9, 2002
Last Updated
June 23, 2005
Sponsor
Favrille
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1. Study Identification

Unique Protocol Identification Number
NCT00036426
Brief Title
Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Unknown status
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Favrille

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Low-Grade
Keywords
lymphoma, vaccine, idiotype, KLH, GM-CSF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
FavId (Id-KLH) active immunotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Scripps Stevens Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Oncology Associates of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Medical Group of North County
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
University of Florida, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
New York Hospital - Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

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

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