Phase I clinical trial of weekly iv 2,3-dihydro-1H-imidazo[1,2-b]pyrazole (IMPY).

In a phase I trial, 2,3-dihydro-1H-imidazo[1,2-b]pyrazole was administered iv weekly at doses ranging from 0.1 to 3.0 g/m2/wk to patients with refractory metastatic solid tumors. Although gastrointestinal toxicity was tolerable and neither granulocyte nor platelet toxicity was seen, significant dose-limiting hemolysis was encountered at doses of 1.5 g/m2/wk. While no definite tumor regressions were seen in the 32 patients evaluable for response, two patients (squamous cell carcinoma of lung and tonsil) had clinically useful improvement.

Phase II study of mitomycin C and vinblastine in women with advanced breast cancer refractory to standard cytotoxic therapy.

The combination of mitomycin C and vinblastine in the dose and schedule used in this study (6 and 5 mg/m2, respectively, every 14 days) was of little clinical efficacy in the management of metastatic breast cancer already refractory to standard chemotherapy and hormonal therapeutic approaches.