Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06
18 Years
N/A
Both
Lymphoma
Trial Information
Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06
OBJECTIVES:
Primary
- Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine
(FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3
follicular B-cell non-Hodgkin's lymphoma who did not receive FavId™ while enrolled on
protocol FAV-ID-06.
Secondary
- Determine the response rate and duration of response in patients treated with this
regimen.
- Determine the response rate and response rate improvement after best response to prior
salvage therapy in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to
timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression
after prior rituximab AND never randomized vs disease progression after randomization to
placebo arm).
Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day
1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for
6 months in the absence of disease progression or unacceptable toxicity. Patients with
stable or responding disease may receive additional treatment as above every 2 months for 1
year (6 treatments) and every 3 months until disease progression.
After completion of study treatment, patients are followed for 30 days or until the start of
subsequent treatment.
PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be
accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
- Grade 1, 2, or 3
- Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH
conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06
- Meets 1 of the following criteria:
- Received salvage therapy after completion of protocol FAV-ID-06
- At least 4 weeks, but no more than 4 months, since prior salvage therapy
- Did not receive salvage therapy after completion of protocol FAV-ID-06
- At least 4 weeks, but no more than 4 months, since completion of prior
treatment on protocol FAV-ID-06
- No history of CNS lymphoma OR meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No history of congestive heart failure
Pulmonary
- No history of compromised pulmonary function
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active bacterial, viral, or fungal infection
- No psychiatric disorder
- No other serious nonmalignant disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior allogeneic transplantation*
- No prior rituximab regimen* other than that administered on protocol FAV-ID-06
(rituximab 375 mg/m^2 IV weekly for 4 weeks)
Chemotherapy
- No prior purine analogues* (e.g., fludarabine or cladribine)
Endocrine therapy
- No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement)
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- Recovered from prior salvage therapy
- No prior or concurrent immunosuppressive therapy
- No prior investigational agents*
- No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered
between completion of protocol FAV-ID-06 and enrollment onto this study
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06
Safety Issue:
No
Principal Investigator
John F. Bender, PharmD
Investigator Role:
Study Chair
Investigator Affiliation:
Favrille
Authority:
Unspecified
Study ID:
CDR0000415573
NCT ID:
NCT00104819
Start Date:
September 2004
Completion Date:
Related Keywords:
- Lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset, New York 11030 |
| Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
| Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
| Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
| UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| Stanford Cancer Center | Stanford, California 94305-5824 |
| Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
| Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
| Sarah Cannon Cancer Center at Centennial Medical Center | Nashville, Tennessee 37203 |
| Rush Cancer Institute at Rush University Medical Center | Chicago, Illinois 60612 |
| Tower Cancer Research Foundation | Beverly Hills, California 90211 |
| Rocky Mountain Cancer Centers - Denver Midtown | Denver, Colorado 80218 |
| Kootenai Cancer Center - Coeur d'Alene | Coeur d'Alene, Idaho 83814 |
| Roger Maris Cancer Center at MeritCare Hospital | Fargo, North Dakota 58122 |
| Helen F. Graham Cancer Center at Christiana Hospital | Newark, Delaware 19718 |
| Sharp Memorial Hospital Cancer Center | San Diego, California 92123 |
| Center for Hematology-Oncology - Boca Raton | Boca Raton, Florida 33486 |
| New Mexico Cancer Center | Albuquerque, New Mexico 87109 |
| Kaiser Permanente Medical Office - Interstate Medical Office Central | Portland, Oregon 97227 |
| Cancer Care Centers of South Texas - Medical Center | San Antonio, Texas 78229 |
