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| Sponsor: | Immunomedics, Inc. |
|---|---|
| Information provided by: | Immunomedics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00040599 |
Purpose
The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Colon Cancer Rectal Cancer Colorectal Neoplasms Colorectal Carcinoma Colorectal Tumor |
Drug: hMN14 (labetuzumab) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
| Official Title: | A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Metastatic/Recurrent Colorectal Carcinomas |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Disease Characteristics:
Prior/Concurrent Therapy:
Patient Characteristics/Inclusion Criteria:
Contacts and Locations| United States, California | |
| Hoag Cancer Center | |
| Newport Beach, California, United States, 92658 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Bay Pines VA Medical Center | |
| St. Petersburg, Florida, United States, 33744 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101-2799 | |
| Germany | |
| University Hospital Dresden | |
| Dresden, Germany, D-01307 | |
| Zentralklinik Bad Berka | |
| Bad Berka, Germany, D99437 | |
| Hungary | |
| University of Szeged Medical Center | |
| Szeged, Hungary | |
| Sweden | |
| Uppsala University Hospital | |
| Uppsala, Sweden, S-75185 | |
| Switzerland | |
| Centre Pluridisciplinaire d'Oncologie | |
| Lausanne, Switzerland, CH-1011 | |
| Study Chair: | William Wegener, MD | Immunomedics, Inc. |
More Information
| Study ID Numbers: | IM-T-hMN14-02 |
| Study First Received: | July 1, 2002 |
| Last Updated: | January 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00040599 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Colon Cancer Rectal Cancer Colorectal Neoplasms Colorectal Carcinoma Colorectal Tumor |
|
Neoplasms by Histologic Type Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Carcinoma Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |