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A phase II trial of amonafide, caracemide, and homoharringtonine in the treatment of patients with advanced renal cell cancer.

Abstract
Forty-eight previously untreated, ambulatory patients with advanced or unresectable renal carcinoma were treated with either amonafide (17 patients), 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 toxicities. One patient each died of pulmonary thromboembolism and sepsis with severe metabolic acidosis on the homoharringtonine arm. An additional 4 patients experienced grade 4 complications including myelosuppression, neurologic dysfunction, and respiratory failure. These severe and unexpected complications caused early termination of accrual to the homoharringtonine arm of the study. These agents have no activity in the treatment of advanced renal cell carcinoma.
AuthorsR S Witte, P Hsieh, P Elson, M M Oken, D L Trump
JournalInvestigational new drugs (Invest New Drugs) Vol. 14 Issue 4 Pg. 409-13 ( 1996) ISSN: 0167-6997 [Print] United States
PMID9157078 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Controlled Clinical Trial, Journal Article, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Harringtonines
  • Imides
  • Isoquinolines
  • Naphthalimides
  • Organophosphonates
  • amonafide
  • Homoharringtonine
  • caracemide
  • Adenine
  • Hydroxyurea
Topics
  • Adenine
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Carcinoma, Renal Cell (drug therapy)
  • Female
  • Harringtonines (administration & dosage)
  • Homoharringtonine
  • Humans
  • Hydroxyurea (administration & dosage, analogs & derivatives)
  • Imides (administration & dosage)
  • Isoquinolines (administration & dosage)
  • Kidney Neoplasms (drug therapy)
  • Male
  • Middle Aged
  • Naphthalimides
  • Organophosphonates
  • Survival Rate
  • Treatment Outcome

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