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[TUT-7 early phase II clinical study for various solid tumors and hematologic malignancies]

T Taguchi1, A Wakui, H Niitani

  • 1Research Institute for Microbial Diseases, Osaka University.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|August 1, 1997
PubMed
Summary

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TUT-7 (menogaril), an anthracycline antibiotic, showed antitumor activity in patients with malignant lymphoma, prostate, and uterine cervical cancers. Common side effects included digestive issues and myelosuppression.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • TUT-7 (menogaril) is a novel anthracycline antitumor antibiotic.
  • Early Phase II clinical trials are crucial for evaluating new cancer therapeutics.

Purpose of the Study:

  • To assess the antitumor efficacy and safety of TUT-7 (menogaril) in patients with various malignant tumors.
  • To determine response rates in specific cancer types including malignant lymphoma, prostate cancer, and uterine cervical cancer.

Main Methods:

  • A nationwide early Phase II study involving 165 patients across 65 institutions.
  • Patients received TUT-7 (menogaril) for 7 or 14 consecutive days at 75 or 100 mg/body/day, with at least two treatment courses.
  • Antitumor efficacy was evaluated in 128 patients; adverse drug reactions and laboratory abnormalities were monitored.

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Main Results:

  • Malignant lymphoma: 1 complete response (CR) and 5 partial responses (PR) in 11 patients (54.5% response rate).
  • Prostate cancer: 1 PR in 3 patients (33.3% response rate).
  • Uterine cervical cancer: 2 PR in 12 patients (16.7% response rate).
  • Frequent adverse events included digestive disorders (anorexia, nausea/vomiting) and malaise.
  • Common laboratory abnormalities were myelosuppression (leukopenia, neutropenia).

Conclusions:

  • TUT-7 (menogaril) demonstrated preliminary antitumor activity in malignant lymphoma, prostate, and uterine cervical cancers.
  • The observed adverse drug reactions and laboratory abnormalities warrant careful monitoring during treatment.
  • Further investigation is needed to establish the therapeutic role of TUT-7 (menogaril).