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Kanglaite Injection Phase I Study



Kanglaite Injection Phase I Study

For Condition: Solid Tumors Refractory To Standard Therapy,Neoplasms
Status: Recruiting
Sponsor(s): Kanglaite-USA ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 18

Location and Contact Information:

Overall Study Official:
RichardWheeler,  Principal Investigator,  Huntsman Cancer Institute

Huntsman Cancer Institue *Recruiting*
Salt Lake City,  Utah,  84112
United States
Recruiting Rita  Gerard 801-585-0550


Additional Information:
Study ID Numbers:
  KN-001-01; 
Study Start Date: June 2001
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031031

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