Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy
Data Collection
Neoplasms
Treatment Study
Summary
Study start date: June 1, 2001
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.16 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location