Neoplasms, Solid Tumors Refractory To Standard Therapy
Conditions
Keywords
MTD, Safety, Pharmacokinetics, Efficacy
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.
Interventions
DRUGKanglaite Injection (KLT)
Sponsors
KangLaiTe USA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed