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Related Experiment Videos

Practical implementation of a modified continual reassessment method for dose-finding trials

S Piantadosi1, J D Fisher, S Grossman

  • 1Johns Hopkins Oncology Center, Baltimore, Maryland, USA.

Cancer Chemotherapy and Pharmacology
|April 29, 1998
PubMed
Summary
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This study presents a modified continual reassessment method (CRM) for efficient cytotoxic drug dose-finding in multi-institutional trials. The novel CRM design requires fewer patients and safely identifies the maximum tolerated dose (MTD).

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Biostatistics

Background:

  • Phase I clinical trials are crucial for determining safe and effective drug dosages.
  • Traditional dose-finding designs can be inefficient and expose patients to excessive toxicity.
  • There is a need for improved methodologies in multi-institutional settings.

Purpose of the Study:

  • To describe a practical, reliable, and efficient dose-finding design for cytotoxic drugs.
  • To adapt the continual reassessment method (CRM) for multi-institutional phase I trials.
  • To enhance the safety and efficiency of dose escalation studies.

Main Methods:

  • Modified the continual reassessment method (CRM) for phase I trials.
  • Utilized a simple dose-toxicity model, patient cohorts of three, and investigator clinical knowledge.

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  • Developed a flexible computer program for streamlined calculations.

    • Main Results:

    • Successfully applied the modified CRM in two dose-finding trials for 9-aminocamptothecin in glioblastoma patients.
    • Efficiently identified the maximum tolerated dose (MTD) in both trials.
    • Required approximately half the number of patients compared to conventional designs, avoiding excessively high doses.

    Conclusions:

    • Demonstrated the feasibility of implementing the modified CRM in multi-institutional settings.
    • Showcased the potential for conducting dose-finding studies with fewer patients.
    • The modified CRM offers a more efficient and safer approach to dose escalation in oncology trials.