The purpose of this study is to determine the highest and most effective dose of the chemotherapy drug, Topotecan in combination with cisplatin that does not result in severe side effects. A goal of this study is to identify the side effects of the treatment plan. This study was opened for patient accrual nationally at Phase I institutions in January 1995. It accrued 19 patients in 4 categories (2 dose levels each for patients with or without bone marrow involvement/extensive bone marrow radiation therapy). The dose limiting toxicity was found to be hematologic, the ANC less than 500 for greater than 7 days. The study was subsequently amended to require that all patients be treated with G-CSF beginning 24 hours after the chemotherapy course is completed. This allowed a dose escalation to dose level 3 (cis- platinum, 60 mg/m2 and topotecan, 1 mg/m2 daily x 3) for patients with no bone marrow involvement or prior extensive radiation therapy to bone marrow sites. Four patients have been enrolled at this dose level but are too early to evaluate as of the date of this report. Four patients with either bone marrow involvement or prior extensive radiation dose limiting toxicity was encountered despite G-CSF at cis-platinum, 45 mg/m2 and topotecan, 0.6 mg/m2/daily x 3. Rather than further de- escalate the dose of topotecan to less than 25% of the dose currently being used in some other pediatric protocols, the study was closed for this group of patients with the recommendation that this combination not be used for patients with bone marrow involvement or extensive prior radiation therapy to the bone marrow.
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