Spots Global Cancer Trial Database for Kanglaite Injection Phase I Study
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Trial Identification
Brief Title: Kanglaite Injection Phase I Study
Official Title: Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy
Study ID: NCT00031031
Interventions
Study Description
Brief Summary: The Kanglaite Injection (KLT)is a novel broad spectrum anti-cancer injection produced from traditional Chinese medicinal herbs (the Coix Seed). It was approved in China in 1995 and has become the most popular anti-cancer drug in China. In June of 2001, the Phase I study of KLT commenced at the Huntsman Cancer Institute in Salt Lake City, Utah, with the objectives of 1) To determine the maximum tolerated dose (MTD) and the safety profile of KLT in patients with refractory solid tumors; 2) To determine the pharmacokinetics of KLT in patients with refractory solid tumors; and 3) To gather preliminary efficacy data. The method of testing is open-label, sequential cohort, dose-escalation study.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Huntsman Cancer Institue, Salt Lake City, Utah, United States
Contact Details
Name: Richard H Wheeler, M.D.
Affiliation: Huntsman Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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