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Related Experiment Videos

[Phase I study on DMDC]

A Gemma1, S Kudoh, M Fukuoka

  • 1Dept. of 4th Internal Medicine, Nippon Medical School.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|November 1, 1996
PubMed
Summary
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This Phase I study evaluated the safety of antimetabolic carcinostatic DMDC in cancer patients. The recommended dosage for Phase II trials is 300 mg/m2 every 2-3 weeks, based on safety and tolerability.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Antimetabolic agents are crucial in cancer therapy.
  • DMDC is a novel antimetabolic carcinostatic compound.
  • Understanding its safety profile is essential for clinical application.

Purpose of the Study:

  • To evaluate the safety and tolerability of DMDC in cancer patients.
  • To determine dose-limiting toxicities and maximum tolerated doses (MTD).
  • To establish recommended dosage and administration schedules for future trials.

Main Methods:

  • Phase I clinical trial involving 28 patients with various malignant tumors.
  • Administered DMDC via intravenous infusion using three schedules: single, single repeated, and 5-consecutive-day.

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  • Dose escalation and safety monitoring, including laboratory tests and adverse events.

    • Main Results:

    • Dose-limiting toxicities were decreases in leukocytes and neutrophils.
    • MTD for single administration was >400 mg/m2; for 5-consecutive-day, it was 40 mg/m2/day.
    • No antitumor effects were observed; DMDC showed no accumulation and had a plasma half-life of 5.2-6.3 hours.

    Conclusions:

    • The recommended dose for Phase II trials is 300 mg/m2 intravenously every 2-3 weeks.
    • DMDC demonstrated a manageable safety profile with dose-dependent myelosuppression.
    • Further investigation is warranted to explore its therapeutic potential.