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Neuro-Oncology 2002 4(4):268-277; doi:10.1093/neuonc/4.4.268
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© 2002 by the Society forNeuro-Oncology

Toward better early-phase brain tumor clinical trials: A reappraisal ofcurrent methods and proposals for future strategies

Frederick F. Lang2, Mark R. Gilbert, Vinay K. Puduvalli, Jeffrey Weinberg, Victor A. Levin, W.K. Alfred Yung, Raymond Sawaya, Gregory N. Fuller and Charles A. Conrad

The Brain Tumor Center, The University of Texas M.D. Anderson CancerCenter, Houston, TX 77005

2 Address correspondence and reprint requests to Frederick F. Lang, Departmentof Neurosurgery, Box 442, The University of Texas M.D. Anderson Cancer Center,1515 Holcombe Blvd., Houston, Texas 77030-4009.


  Abstract

Although no optimal treatment is currently available for malignant braintumors, as the molecular mechanisms underlying brain tumor development havebeen delineated, new chemotherapeutic agents that act directly on specificmolecular targets have become available. Defining a specific molecular targetraises the possibility that the molecular effects of a given agent can beanalyzed in patients in a clinical trial. Specifically, whereas standard phaseI and II clinical trials classically determine the safety and efficacy ofagents by using indirect global end points, these new biological agents affordthe opportunity to incorporate molecular end points into phase I and IIclinical trials to determine whether the agent under investigation is actuallydoing what it was intended to do. This work presents avenues for improvingcurrent brain tumor clinical trial designs based on the molecular specificityof new agents and the unique features of brain tumors. Specifically, theauthors recommend brain-applicable phase I and II clinical trial strategiesthat take advantage of the targeted nature of new agents to maximizeinformation about their efficacy, toxicity, and molecular effects.

Received March 15, 2002; Accepted June 18, 2002


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