Background: The single-agent activity of the vinca alkaloid vinorelbine (Navel-bine®) in patients with relapsed or refractory nonseminomatous germ cell tumors was evaluated. Patients and Methods: Seven heavily pretreated patients received weekly an infusion (30 min) of vinorelbine at a dose of 30 mg/m2. Results: No responses (complete and partial remissions or no change) were achieved. We observed myelotoxicity with grade 3 leukopenia in 4 patients and grade 3 throm-bocytopenia in 2. No neurotoxicity was noted. Two patients had skin reactions at the site of infusion. Conclusions: Due to slow recruitment of patients, this phase II study has been terminated early. No role for vinorelbine was found in this patient group with an extremely unfavorable prognosis. The use of vinorelbine in combination regimens remains an issue of investigation.

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