Rituxan Plus FavId (Idiotype Vaccine) for Low-Grade Non-Hodgkin's Lymphoma - Full Text View

Sponsored by:	Favrille
Information provided by:	Favrille
ClinicalTrials.gov Identifier:	NCT00041730

Purpose

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.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Biological: Id-KLH	Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by Favrille:

Estimated Enrollment:	90
Study Start Date:	July 2002

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.

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041730

Locations

United States, California
Oncology Associates of San Diego
San Diego, California, United States, 92123
Tower Hematology Oncology Medical Group
Los Angeles, California, United States, 90048
University of California, San Diego
La Jolla, California, United States, 92093
University California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Florida, Jacksonville
Jacksonville, Florida, United States, 32209
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Louisiana
Ochsner Clinical Foundation
New Orleans, Louisiana, United States, 70121
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
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Oncology/Hematology Care Clinical Cancer Institute
Cincinnati, Ohio, United States, 45219
University Hospitals of Cleveland Case Western, Ireland Cancer Center
Cleveland, Ohio, United States, 44106
United States, Tennessee
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22902

Sponsors and Collaborators

Favrille

More Information

Company website This link exits the ClinicalTrials.gov site

Study ID Numbers:	FavId-04
Study First Received:	July 15, 2002
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00041730
Health Authority:	United States: Food and Drug Administration

Keywords provided by Favrille:

lymphoma
vaccine
idiotype

KLH
GM-CSF
FavId

Study placed in the following topic categories:

Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
Immunoglobulin Idiotypes
Rituximab

B-cell lymphomas
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009