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| Sponsor: | Unither Pharmaceuticals |
|---|---|
| Information provided by: | Unither Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00050375 |
Purpose
This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: oregovomab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Intravenous OvaRex® MAb-B43.13 as Post Chemotherapy Consolidation for Epithelial Carcinoma of Ovarian, Tubal or Peritoneal Origin |
| Estimated Enrollment: | 354 |
| Study Start Date: | December 2002 |
| Study Completion Date: | December 2007 |
This a Phase III, double-blind, placebo-controlled, multi-center study of intravenous OvaRex® MAb-B43.13 as post-chemotherapy consolidation for epithelial carcinoma of ovarian, tubal, or peritoneal origin.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Comprehensive Cancer Institute | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Western Regional Community Clinical Oncology Program | |
| Phoenix, Arizona, United States, 85006 | |
| United States, Arkansas | |
| Little Rock Hematology Oncology Assoc. | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Gynecologic Oncology Associates | |
| Newport Beach, California, United States, 92663 | |
| St. Jude Medical Center | |
| Fullerton, California, United States, 92835 | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Wilshire Oncology Medical Group | |
| La Verne, California, United States, 91750 | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095-1740 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| University of California, Irvine | |
| Orange, California, United States, 92868 | |
| Sharp Memorial Hospital | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Rocky Mountain Cancer Center-Midtown | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Northwestern Connecticut Oncology Hematology Associates, LLP | |
| Torrington, Connecticut, United States, 06790 | |
| University of Connecticut Cancer Center | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Florida | |
| Florida Hospital Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| Florida Gynecologic Oncology | |
| Fort Myers, Florida, United States, 33901 | |
| H. Lee Moffitt Cancer Center and Research | |
| Tampa, Florida, United States, 33612-9497 | |
| Pensacola Research Consultants | |
| Pensacola, Florida, United States, 32504 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| The University of Chicago Hospitals | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Michiana Hematology Oncology PC | |
| South Bend, Indiana, United States, 46617 | |
| St. Vincent Gynecologic Oncology | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| Louisville Oncology | |
| Louisville, Kentucky, United States, 40202 | |
| Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Lake Charles Medical Surgical Clinic | |
| Lake Charles, Louisiana, United States, 70601 | |
| Hematology and Oncology Specialists | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Maryland | |
| The Harry and Jeanette Weinberg Cancer Institute | |
| Baltimore, Maryland, United States, 21237-3998 | |
| United States, Massachusetts | |
| New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Mississippi | |
| Women's Specialty Center | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center | |
| Columbia, Missouri, United States, 65203 | |
| United States, New Jersey | |
| Jersey Shore Medical Center | |
| Neptune, New Jersey, United States, 07754 | |
| United States, New York | |
| St. Vincent's Comprehensive Cancer Center | |
| New York City, New York, United States, 10011 | |
| SUNY-HSC Syracuse, Crouse Hospital | |
| Syracuse, New York, United States, 13210 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Nyack Hospital | |
| Nyack, New York, United States, 10960 | |
| United States, North Carolina | |
| Blumenthal Cancer Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| GYN Oncology and Pelvic Surgery Associates | |
| Columbus, Ohio, United States, 43222 | |
| Medical College of Ohio Cancer Institute | |
| Toledo, Ohio, United States, 43614-5809 | |
| University Hospital - Health Systems | |
| Cleveland, Ohio, United States, 44106 | |
| ProMedica Health Systems | |
| Toledo, Ohio, United States, 43606 | |
| United States, Oklahoma | |
| Oklahoma University Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Northwest Cancer Specialists-Northrup | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213-3180 | |
| United States, Rhode Island | |
| Brown University School of Medicine | |
| Providence, Rhode Island, United States, 02905 | |
| United States, South Carolina | |
| South Carolina Oncology Associates | |
| Columbia, South Carolina, United States, 29203 | |
| Gynecologic Oncology Research and Development | |
| Greenville, South Carolina, United States, 29601 | |
| United States, Tennessee | |
| Chattanooga GYN Oncology | |
| Chattanooga, Tennessee, United States, 37403 | |
| West Clinic, PC | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Arlington Cancer Center | |
| Arlington, Texas, United States, 76012 | |
| Southwest Regional Cancer Center | |
| Austin, Texas, United States, 78705 | |
| The Center for Cancer and Blood Disorders | |
| Fort Worth, Texas, United States, 76104 | |
| Texas Oncology, PA | |
| Dallas, Texas, United States, 75246-2006 | |
| Texas Oncology | |
| Fort Worth, Texas, United States, 76104 | |
| Univ. of Texas SW Medical Center at Dallas | |
| Dallas, Texas, United States, 75235-9032 | |
| United States, Utah | |
| Utah Cancer Specialists | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Virginia | |
| VA Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Carilion GYN Oncology Associates | |
| Roanoke, Virginia, United States, 24014 | |
| United States, Washington | |
| Cancer Care Northwest | |
| Spokane, Washington, United States, 99218 | |
| Northwest Cancer Specialists-Vancouver | |
| Vancouver, Washington, United States, 98684 | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98104 | |
More Information
| Study ID Numbers: | OVA-Gy-17 |
| Study First Received: | December 5, 2002 |
| Last Updated: | December 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00050375 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
OvaRex ovarian CA125 |
murine antibody immunotherapy |
|
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |