Phase I study with neocarzinostatin: tolerance to two hour infusion and continuous infusion.

Abstract

Neocarzinostatin (NCZ), an acidic polypeptide antibiotic, was given to 47 patients with cancer and leukemia, and tolerance to two schedules, a single dose given as a 2 hour infusion and a continuous infusion over 5 days was investigated. Immediate reactions, including fever, chills, rigor, hypertension and mental confusion, were dose-limiting for the 2 hour infusion schedule, occurring at 3000 U/m2 and higher. Continuous administration for 5 days eliminated the immediate reactions and then hematological toxicity--often prolonged leukopenia and thrombocytopenia--became dose-limiting. Other toxicities of NCZ at both dose schedules included anemia, fever and chills, anorexia, nausea and vomiting, hepatic dysfunction, azotemia, hypophosphatemia, aminoaciduria, stomatitis, phlebitis and/or cellulitis at the venous infusion site and pruritus. Patients with solid tumors who had received little or no prior chemotherapy and had good bone marrow reserve tolerated up to 6000 U/m2/24 hours X 5 days. One patient with previously treated acute myelocytic leukemia was induced into a good partial remission lasting 10 weeks.

• Authors: T Ohnuma, C Nogeire, J Cuttner, J F Holland
• Journal: Cancer (Cancer) Vol. 42 Issue 4 Pg. 1670-9 (Oct 1978) ISSN: 0008-543X [Print] United States
• PMID: 152143 (Publication Type: Journal Article, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antibiotics, Antineoplastic
• Zinostatin

Topics

• Adolescent
• Adult
• Aged
• Antibiotics, Antineoplastic (administration & dosage)
• Bone Marrow (drug effects)
• Child
• Drug Administration Schedule
• Drug Evaluation
• Drug Tolerance
• Female
• Fever (chemically induced)
• Humans
• Hyperbilirubinemia (chemically induced)
• Infusions, Parenteral
• Leukemia (drug therapy)
• Leukemia, Myeloid, Acute (drug therapy)
• Male
• Middle Aged
• Neoplasms (drug therapy)
• Remission, Spontaneous
• Uremia (chemically induced)
• Zinostatin (administration & dosage, toxicity)