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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000415573 | Registry Identifier | PDQ (Physician Data Query) | |
| CWRU-FVID-2404 | |||
| CWRU-100415 | |||
| CASE-2404 | |||
| FAV-WIRB-20041124 |
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Withdrawn as company has shut down and filed for bankruptcy
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Vaccines made from a person's cancer cells may make the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous immunoglobulin idiotype-KLH conjugate vaccine | Biological | |||
| sargramostim | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)â„¢ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)â„¢ during participation on study Favld-06 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate by modified Cheson Criteria | ||
| Duration of response by modified Cheson Criteria | ||
| Time to progression |
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DISEASE CHARACTERISTICS:
Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavIdâ„¢) while enrolled on protocol FAV-ID-06
Meets 1 of the following criteria:
Received salvage therapy after completion of protocol FAV-ID-06
Did not receive salvage therapy after completion of protocol FAV-ID-06
No history of CNS lymphoma OR meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| John F. Bender, PharmD | Favrille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Tower Cancer Research Foundation |
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| Response rate improvement |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Rebecca and John Moores UCSD Cancer Center | La Jolla | California | 92093-0960 | United States |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego | San Diego | California | 92120 | United States |
| Sharp Memorial Hospital Cancer Center | San Diego | California | 92123 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143-0324 | United States |
| Stanford Cancer Center | Stanford | California | 94305-5824 | United States |
| Kaiser Permanente Medical Center - Vallejo | Vallejo | California | 94589 | United States |
| Rocky Mountain Cancer Centers - Denver Midtown | Denver | Colorado | 80218 | United States |
| Helen F. Graham Cancer Center at Christiana Hospital | Newark | Delaware | 19713 | United States |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Center for Hematology-Oncology - Boca Raton | Boca Raton | Florida | 33486 | United States |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612-9497 | United States |
| Kootenai Cancer Center - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush Cancer Institute at Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Greater Baltimore Medical Center Cancer Center | Baltimore | Maryland | 21204 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202-2608 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| New Mexico Cancer Center | Albuquerque | New Mexico | 87109 | United States |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | The Bronx | New York | 10466-2604 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| Roger Maris Cancer Center at MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45219 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Kaiser Permanente Medical Office - Interstate Medical Office Central | Portland | Oregon | 97227 | United States |
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Sarah Cannon Cancer Center at Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Cancer Care Centers of South Texas - Medical Center | San Antonio | Texas | 78229 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98104 | United States |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| C081222 | sargramostim |
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