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Brief Title: Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma
Official Title: A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients With Inoperable Locally Advanced or Metastatic Melanoma.
Study ID: NCT00068211
Brief Summary: This is a Phase II, non-randomized, open label study of ILX651 in patients with inoperable locally advanced or metastatic melanoma. Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate for all patients who are treated with ILX651. The secondary objectives are to determine the progression free survival at 18 weeks, duration of response, time to tumor progression, survival, safety/tolerability of ILX651 and to evaluate the pharmacokinetic profile.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Cancer Center at Scottsdale, Scottsdale, Arizona, United States
Univ of Arizona Cancer Center, Tucson, Arizona, United States
USC / Norris Cancer Center, Los Angeles, California, United States
Cancer Institute Medical Group, Santa Monica, California, United States
Univ of Colorado Cancer Center/ Anschutz Cancer, Aurora, Colorado, United States
US Oncology / Cancer Centers of Florida, Orlando, Florida, United States
US Oncology / Kansas City Oncology, Overland Park, Kansas, United States
Beth Israel Medical Center, Boston, Massachusetts, United States
US Oncology / Kansas City Oncology and Hematology, Kansas City, Missouri, United States
Center for Cancer Care Research, St. Louis, Missouri, United States
US Oncology / Albany Regional Cancer Center, Albany, New York, United States
US Oncology / Dayton Oncology and Hematology, Kettering, Ohio, United States
US Oncology / Cancer Centers of the Carolinas, Greenville, South Carolina, United States
US Oncology / Mary Crowley Medical Research, Dallas, Texas, United States
US Oncology /Texas Oncology, Ft. Worth, Texas, United States
St. Luke's Episcopal Hospital, Houston, Texas, United States
US Oncology/ Tyler Cancer Center, Tyler, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
US Oncology / Cancer Care Northwest, Spokane, Washington, United States