search
Back to results

Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma

Primary Purpose

Non-Hodgkin's Lymphoma

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

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring lymphoma, vaccine, idiotype, KLH, GM-CSF, FavId

Eligibility Criteria

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

Inclusion Criteria 18 years of age or older Patients that are treatment naive OR Relapsed or refractory following chemotherapy OR Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been given as second-line therapy following an initial response to chemotherapy or in combination with chemotherapy for initial therapy of their disease. Tumor accessible for biopsy or previously existing recent biopsy material Measurable disease after node biopsy Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification) Performance status (ECOG) of 0, 1 or 2 Absolute Granulocyte count > 1,000/mm3 Platelets > 100,000/mm3 Total Bilirubin <2 mg/dL AST and ALT <2x Upper Limit of Normal Creatinine < 1.5 mg/dL Exclusion Criteria Patients who are refractory to Rituxan(R) Note: Patients who did not attain a CR or PR are considered to be refractory More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment regimens) Treatment w/Fludarabine within 9 months of study entry Patients with > 5,000 lymphocytes Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients whose idiotype has changed are eligible for retreatment with new idiotype) Concurrent immunosuppressive therapy (high-dose steroids; ect.) Known history of CNS lymphoma or meningeal lymphomatosis HIV positive Serious non-malignant disease (e.g., psychiatric disorders, compromised pulmonary function (e.g. active asthma, COPD, pneumonitis, bronchiolitis obliterans), 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 non-melanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for >2 years Treatment with an investigational drug within 8 weeks prior to study entry Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving study treatment.

Sites / Locations

  • University of California, San Diego
  • Tower Hematology Oncology Medical Group
  • Oncology Associates of San Diego
  • University California, San Francisco
  • University of Florida, Jacksonville
  • H. Lee Moffitt Cancer Center
  • Northwestern University
  • Ochsner Clinical Foundation
  • Henry Ford Hospital
  • New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
  • Oncology/Hematology Care Clinical Cancer Institute
  • University Hospitals of Cleveland Case Western, Ireland Cancer Center
  • The Ohio State University
  • The Sarah Cannon Cancer Center
  • University of Virginia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 15, 2002
Last Updated
September 29, 2009
Sponsor
Favrille
search

1. Study Identification

Unique Protocol Identification Number
NCT00041730
Brief Title
Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma
Official Title
Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Unknown status
Study Start Date
July 2002 (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 is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.
Detailed Description
The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype. Secondary objectives are the determination of overall objective response rate, duration of response and time to progression. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in production of 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. For vaccines which produce primarily an antibody response, there is a concern that combining immunotherapy with Rituxan®, which produces a rapid and sustained (up to 6 to 9 months post-treatment in 83% of patients) depletion of circulating and tissue-based B-cells, would blunt any antibody response. For vaccines that induce strong T-cell responses like Id-KLH plus GM-CSF, there is evidence in mice that depleting the host of B-cells could actually increase the T-cell response to the vaccine. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation. T-cell response to both the patient's Idiotype and KLH will be measured during this trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
lymphoma, vaccine, idiotype, KLH, GM-CSF, FavId

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Id-KLH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 18 years of age or older Patients that are treatment naive OR Relapsed or refractory following chemotherapy OR Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been given as second-line therapy following an initial response to chemotherapy or in combination with chemotherapy for initial therapy of their disease. Tumor accessible for biopsy or previously existing recent biopsy material Measurable disease after node biopsy Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification) Performance status (ECOG) of 0, 1 or 2 Absolute Granulocyte count > 1,000/mm3 Platelets > 100,000/mm3 Total Bilirubin <2 mg/dL AST and ALT <2x Upper Limit of Normal Creatinine < 1.5 mg/dL Exclusion Criteria Patients who are refractory to Rituxan(R) Note: Patients who did not attain a CR or PR are considered to be refractory More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment regimens) Treatment w/Fludarabine within 9 months of study entry Patients with > 5,000 lymphocytes Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients whose idiotype has changed are eligible for retreatment with new idiotype) Concurrent immunosuppressive therapy (high-dose steroids; ect.) Known history of CNS lymphoma or meningeal lymphomatosis HIV positive Serious non-malignant disease (e.g., psychiatric disorders, compromised pulmonary function (e.g. active asthma, COPD, pneumonitis, bronchiolitis obliterans), 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 non-melanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for >2 years Treatment with an investigational drug within 8 weeks prior to study entry Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving study treatment.
Facility Information:
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
University California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Florida, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Ochsner Clinical Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
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
Oncology/Hematology Care Clinical Cancer Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals of Cleveland Case Western, Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma

We'll reach out to this number within 24 hrs