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Sponsors and Collaborators: |
James Graham Brown Cancer Center University of Louisville |
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Information provided by: | James Graham Brown Cancer Center |
ClinicalTrials.gov Identifier: | NCT00299689 |
The purpose of this study is to determine whether ONTAK is an effective treatment in patients with Stage IV Melanoma
Condition | Intervention | Phase |
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Malignant Melanoma |
Drug: Denileukin diftitox |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of ONTAK With Metastatic Melanoma |
Estimated Enrollment: | 77 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2016 |
This is a Phase II clinical trial to determine whether administration of ONTAK will result in a significant response rate in patients with metastatic melanoma.
Although the development of effective immunotherapy and the characterization of multiagent chemotherapy regimens have substantially improved in the treatment of metastatic malignant melanoma, the overall results remain dismal with a 6% five year survival rate for stage IV disease. Of the common adult-onset cancers, melanoma is widely held to be the most amenable to immunological intervention.
The primary objective of this study is to determine the response rate and the overall survival of patients with metastatic malignant melanoma treated with two regimens of ONTAK.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Only patients with distant metastases from cutaneous or mucosal melanoma or melanoma of unknown primary are eligible for this study.
Only patients with distant metastases from cutaneous or mucosal melanoma or melanoma of unknown primary are eligible for this study. All patients must fulfill the following criteria:
Contact: Bev Taft, RN, BSN | 502-852-4143 | bstaft01@gwise.louisville.edu |
United States, Kentucky | |
James Graham Brown Cancer Center | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Bev Taft, RN, BSN,OCN 502-852-4146 bstaft01@gwise.louisville.edu | |
Sub-Investigator: Donald Miller, MD, PhD |
Principal Investigator: | Jason Chesney, MD, PhD | University of Louisville |
Study ID Numbers: | 076.06 |
Study First Received: | March 3, 2006 |
Last Updated: | June 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00299689 |
Health Authority: | United States: Food and Drug Administration |
Melanoma Metastatic Stage IV Ontak |
Neuroectodermal Tumors Denileukin diftitox Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nevi and Melanomas Pharmacologic Actions |