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

Sponsor

Favrille (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00041730

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Biological: Id-KLH	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	La Jolla	California	United States	92093
2	Tower Hematology Oncology Medical Group	Los Angeles	California	United States	90048
3	Oncology Associates of San Diego	San Diego	California	United States	92123
4	University California, San Francisco	San Francisco	California	United States	94143
5	University of Florida, Jacksonville	Jacksonville	Florida	United States	32209
6	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33612
7	Northwestern University	Chicago	Illinois	United States	60611
8	Ochsner Clinical Foundation	New Orleans	Louisiana	United States	70121
9	Henry Ford Hospital	Detroit	Michigan	United States	48202
10	New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center	Bronx	New York	United States	10466
11	Oncology/Hematology Care Clinical Cancer Institute	Cincinnati	Ohio	United States	45219
12	University Hospitals of Cleveland Case Western, Ireland Cancer Center	Cleveland	Ohio	United States	44106
13	The Ohio State University	Columbus	Ohio	United States	43210
14	The Sarah Cannon Cancer Center	Nashville	Tennessee	United States	37203
15	University of Virginia	Charlottesville	Virginia	United States	22902