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Early clinical trial with quelamycin
Abstract:
Quelamycin (triferric doxorubicin) is a derivative of Adriamycin with different pharmacologic properties. Our phase I clinical study of quelamycin includes 37 patients with a wide spectrum of solid tumors. The recommended dose in good-risk patients is 150 mg/m2, given as a 1-hour infusion every 3 weeks. The dose-limiting factor appears to be myelosuppression, especially leukopenia. Other toxic effects include gastrointestinal intolerance and alopecia. Chills and fever are commonly encountered and might be due to an excess of free iron in currently available preparations. Cardiotoxicity could not be properly assessed. An objective antitumor effect was seen in patients with lung, gastric, colon, and ovarian carcinomas as well as osteogenic sarcoma. Further preclinical and clinical studies with an improved pharmaceutic formulation of the drug are highly desirable.
Insights
Quelamycin, a novel Adriamycin derivative, shows antitumor effects in various solid tumors. The recommended dose is 150 mg/m2, with myelosuppression as the main dose-limiting toxicity.
Area of Science:
- Oncology
- Pharmacology
Background:
- Quelamycin (triferric doxorubicin) is a novel Adriamycin derivative with distinct pharmacologic properties.
- Adriamycin derivatives are critical in cancer chemotherapy.
Purpose of the Study:
- To evaluate the safety and efficacy of quelamycin in a Phase I clinical trial.
- To determine the recommended dosage and identify dose-limiting toxicities of quelamycin.
Main Methods:
- A Phase I clinical study involving 37 patients with diverse solid tumors.
- Administered quelamycin as a 1-hour infusion every 3 weeks.
- Monitored for adverse events, antitumor responses, and determined the maximum tolerated dose.
Main Results:
- The recommended dose for good-risk patients is 150 mg/m2 every 3 weeks.
- Myelosuppression, particularly leukopenia, was the primary dose-limiting toxicity.
- Observed objective antitumor effects in lung, gastric, colon, ovarian carcinomas, and osteogenic sarcoma.
- Common toxicities included gastrointestinal intolerance, alopecia, chills, and fever.
Conclusions:
- Quelamycin demonstrates potential antitumor activity across a range of solid tumors.
- Further investigation with improved pharmaceutical formulations is warranted.
- Myelosuppression and gastrointestinal issues necessitate careful patient monitoring and dose adjustments.
