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.

Condition	Treatment or Intervention	Phase
Solid Tumors Refractory To Standard Therapy Neoplasms	Drug: Kanglaite Injection (KLT)	Phase I

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

• Patients with histological evidence of malignancy that has become refractory to standard therapy, or for whom effective standard therapy does not exist.
• Patients with an estimated life-expectancy of at least 3 months
• Patients with a Karnofsky Performance Score of at least 60%
• Patients with no history of congestive heart failure (CHF), and normal ejection fraction by echocardiography
• Patients with adequate renal and hepatic function
• Patients with adequate bone marrow status

Utah
      Huntsman Cancer Institue, Salt Lake City,  Utah,  84112,  United States

Study chairs or principal investigators

Richard H Wheeler, M.D.,  Principal Investigator,  Huntsman Cancer Institute   

Study ID Numbers:  KN-001-01
Record last reviewed:  March 2001
Record first received:  February 20, 2002
ClinicalTrials.gov Identifier:  NCT00031031
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10