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Phase I clinical trial with carbetimer
P Dodion1, D de Valeriola, J J Body
1Unité de Chimiothérapie, Institut Jules Bordet, de l'Université Libre de Bruxelles, Brussels, Belgium.
European Journal of Cancer & Clinical Oncology
|February 1, 1989
Summary
Carbetimer, a novel anticancer agent, shows antitumor activity against various solid tumors with minimal traditional chemotherapy side effects. Major toxicities include dose-dependent hypercalcemia and neurotoxicity with prolonged use.
Area of Science:
- Oncology
- Pharmacology
- Polymer Chemistry
Background:
- Carbetimer is a low molecular weight polymer distinct from existing anticancer agents.
- It exhibits moderate antitumor activity in preclinical models against several carcinomas.
Purpose of the Study:
- To evaluate the safety and efficacy of carbetimer in patients with solid tumors.
- To determine dose-limiting toxicities and preliminary antitumor responses.
Main Methods:
- A phase I dose-escalation trial was conducted in 26 patients with solid tumors.
- Carbetimer was administered intravenously over 5 consecutive days, with doses ranging from 1.08 to 11 g/m2/day.
- Patients were monitored for adverse events and antitumor responses.
Main Results:
- Carbetimer demonstrated an unusual side-effect profile, with minimal leukopenia, thrombocytopenia, alopecia, and mucositis.
- The primary dose-limiting toxicities were hypercalcemia and neurotoxicity, which were dose- and duration-dependent.
- Significant antitumor responses were observed in two patients with malignant melanoma, with one achieving long-term disease-free survival.
Conclusions:
- Carbetimer is a novel compound with a unique toxicity profile and promising antitumor activity, particularly against malignant melanoma.
- Further investigation in phase II trials is warranted to confirm its efficacy and safety in specific cancer types.