Clinical trial NCT00041730: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: lymphoma
vaccine
idiotype
KLH
GM-CSF
FavId
Lead sponsor: Favrille
Sponsor class: INDUSTRY
First posted: 2002-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: San Diego
country: United States
facility: Oncology Associates of San Diego
state: California
city: San Francisco
country: United States
facility: University California, San Francisco
state: California
city: Jacksonville
country: United States
facility: University of Florida, Jacksonville
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinical Foundation
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Bronx
country: United States
facility: New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
state: New York
city: Cincinnati
country: United States
facility: Oncology/Hematology Care Clinical Cancer Institute
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Case Western, Ireland Cancer Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: