Kanglaite Injection Phase I Study

KangLaiTe USA16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors Refractory To Standard Therapy Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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

Kanglaite Injection Phase I Study

Overview

Conditions

Interventions

Eligibility

Locations (1)