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Indicine-N-oxide: a new antitumor agent
Cancer Treatment Reports
|January 1, 1981
Summary
Indicine-N-oxide shows promise as an anticancer drug, particularly against leukemia and colon carcinoma, with antimitotic effects. Further Phase II studies are recommended to confirm its efficacy and safety profile.
Area of Science:
- Pharmacology
- Oncology
- Drug Development
Background:
- Indicine-N-oxide, a pyrrolizidine derivative, exhibits activity against murine P388 leukemia.
- Antitumor effects are hypothesized to involve antimitotic actions and chromosomal damage.
- The specific active metabolite remains unidentified.
Purpose of the Study:
- To evaluate the antitumor activity and toxicity of Indicine-N-oxide.
- To determine recommended doses for further clinical investigation.
- To explore potential efficacy in various cancer types, including colon carcinoma and leukemias.
Main Methods:
- Preclinical evaluation in murine leukemia models.
- Phase I clinical trials to establish dosing and safety.
- Phase II clinical trials in refractory leukemia and other tumor types.
Main Results:
- Route and schedule dependency demonstrated.
- Myelosuppression identified as the primary toxicity.
- Possible responsiveness observed in colon carcinoma; several tumor types showed stability.
- Phase II study in refractory leukemia yielded three responses (one complete) in seven patients.
Conclusions:
- Indicine-N-oxide demonstrates potential as an anticancer agent, particularly for leukemias and colon carcinoma.
- Further Phase II studies are warranted across a broader range of tumors.
- Understanding the active metabolite is crucial for optimizing therapeutic strategies.