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Phase I studies with Baker's Antifol (BAF) (NSC 139105)
Cancer
|August 1, 1976
Summary
Baker's Antifol (BAF), a novel dihydrofolate reductase inhibitor, showed biologic effects in cancer patients at higher doses. While toxicities like myelosuppression and dermatitis occurred, BAF warrants further clinical trials as a potential chemotherapeutic agent.
Area of Science:
- Oncology
- Pharmacology
Background:
- Baker's Antifol (BAF) is a novel active-site directed inhibitor of dihydrofolate reductase.
- Phase I clinical trials were initiated to evaluate the safety and preliminary efficacy of BAF in adult cancer patients.
Purpose of the Study:
- To assess the safety and tolerability of BAF through dose escalation.
- To identify preliminary biologic effects and potential anti-cancer activity of BAF.
Main Methods:
- Phase I study involving 58 adult cancer patients.
- Dose escalation from 10 to 250 mg/m2/day for 5 days, with treatment courses repeated every 2-3 weeks.
- Monitoring for toxicities including myelosuppression, dermatitis, and stomatitis, and assessment of liver function.
Main Results:
- Biologic effects were observed primarily at doses exceeding 100 mg/m2/day.
- Myelosuppression occurred in 19% of trials; dermatitis in 12-30%; stomatitis in 7-38%.
- Toxicity was correlated with impaired liver function. Two partial responses were noted in lung and bladder cancer patients.
Conclusions:
- BAF demonstrates activity as a chemotherapeutic agent.
- Further clinical trials are warranted to explore BAF's efficacy in various malignancies.