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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2004 by Favrille.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Favrille
ClinicalTrials.gov Identifier:
NCT00041730
First received: July 15, 2002
Last updated: September 29, 2009
Last verified: October 2004
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Tower Hematology Oncology Medical Group
Los Angeles, California, United States, 90048
Oncology Associates of San Diego
San Diego, California, United States, 92123
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
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
The Ohio State University
Columbus, Ohio, United States, 43210
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00041730     History of Changes
Obsolete Identifiers: NCT00060164
Other Study ID Numbers: FavId-04
Study First Received: July 15, 2002
Last Updated: September 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Favrille:
lymphoma
vaccine
idiotype
KLH
GM-CSF
FavId

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014