Human tumor stem cell assay. A prospective clinical trial.

Reported is a prospective clinical trial involving 53 patients evaluating the usefulness of a human tumor stem cell assay for selecting chemotherapeutic agents for patients with advanced malignancies. Three patients could not be directed by the cloning system results because of inadequate tumor growth or other difficulties. Cloning efficiency exceeded 90%. Fewer than 3% of soft agar cultures were contaminated by fungal elements. True-positive rates of 65% and true-negative rates of 90% for the cloning assay in predicting response (or lack of response) to chemotherapeutic agents were seen. Preliminary data on the predictive ability of the assay in determining response to adjunctive hyperthermia are presented. With the derivation of mean doubling times from the assay, individualized treatments may be designed for patients with advanced malignancies.