BACKGROUND In an attempt to improve the complete remission and cure rate of advanced, bulky, high-risk germ cell cancer in men, a "high-dose" cisplatin, vinblastine, bleomycin, and etoposide (PVeBV) regimen was introduced. METHODS Ten men with biopsy-proven germ cell tumors who had one or more poor prognostic features were treated with PVeBV. RESULTS Six of the 10 had complete remissions and are long-term survivors. The most devastating toxicity, which resulted in the death of three patients, was progressive respiratory failure. It was postulated that renal tubular injury prolonged the renal clearance of bleomycin, intensifying the patient's pulmonary exposure to this drug and increased the susceptibility to pulmonary injury at lower than expected cumulative doses of bleomycin. CONCLUSIONS Modifications of the regimen to reduce toxicity without diminishing the efficacy should be considered before PVeBV is adopted for general use.