A PHASE-II TRIAL OF AMONAFIDE, CARACEMIDE, AND HOMOHARRINGTONINE IN THE TREATMENT OF PATIENTS WITH ADVANCED RENAL-CELL CANCER

Forty-eight previously untreated, ambulatory patients with advanced or unresectable renal carcinoma were treated with either amonafide (17 p atients), caracemide (17 patients), or homoharringtonine (14 patients) . No objective responses were observed in any of the treatment cohorts . Amonafide and caracemide were well tolerated with no unexpected toxi cities. One patient each died of pulmonary thromboembolism and sepsis with severe metabolic acidosis on the homoharringtonine arm. An additi onal 4 patients experienced grade 4 complications including myelosuppr ession, neurologic dysfunction, and respiratory failure. These severe and unexpected complications caused early termination of accrual to th e homoharringtonine arm of the study. These agents have no activity in the treatment of advanced renal cell carcinoma.