A phase I study of Cytembena

S. Frytak, C. G. Moertel, A. J. Schutt, D. L. Ahmann, J. V. Donadio, Richard M Weinshilboum

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Twenty two patients were given progressively increasing doses of Cytembena to determine toxicity patterns and to establish a dosage which produces definite but clinically tolerable toxicity when the drug is given by intravenous injection in a 5 day intensive course. Toxicity consisted primarily of nausea, vomiting, arm pain, and transiently decreased renal function. At higher doses, an 'autonomic storm' phenomenon was observed consisting of hypertension, tachycardia, tachypnea, hyperperistalsis, frequent explosive defecation, facial flushing and paresthesias, and chest pain with accompanying ischemic EKG changes. There was no evidence of mucocutaneous, hepatic, or hematologic toxic effects. Toxicity was dose related, first being recognized at a daily dose of 300 mg/m 2 and becoming clinically intolerable at a daily dose of 475 mg/m 2. No permanent damage was observed in any of the organ systems monitored. An acceptable treatment regimen for most patients is 400 mg/m 2/day for 5 days. Patient discomfort can be reduced by dividing each day's dose into two intravenous injections given at an interval of at least 6 hours. Coronary artery disease and impaired renal function should be contraindications to Cytembena therapy, and caution should be employed in the patients with significant impairment of liver function. Two of 22 patients, both with far advanced carcinoma and previous chemotherapy failures, showed a favorable objective response to Cytembena therapy. Phase II studies to assess the magnitude of the drug's antineoplastic activity seem warranted.

Original languageEnglish (US)
Pages (from-to)1248-1255
Number of pages8
JournalCancer
Volume37
Issue number3
DOIs
StatePublished - 1976

Fingerprint

Intravenous Injections
Kidney
Tachypnea
Defecation
Paresthesia
Poisons
Liver
Drug-Related Side Effects and Adverse Reactions
Chest Pain
Tachycardia
Antineoplastic Agents
Nausea
Vomiting
Coronary Artery Disease
Electrocardiography
Therapeutics
bromebric acid
Hypertension
Carcinoma
Drug Therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Frytak, S., Moertel, C. G., Schutt, A. J., Ahmann, D. L., Donadio, J. V., & Weinshilboum, R. M. (1976). A phase I study of Cytembena. Cancer, 37(3), 1248-1255. https://doi.org/10.1002/1097-0142(197603)37:3<1248::AID-CNCR2820370304>3.0.CO;2-P

A phase I study of Cytembena. / Frytak, S.; Moertel, C. G.; Schutt, A. J.; Ahmann, D. L.; Donadio, J. V.; Weinshilboum, Richard M.

In: Cancer, Vol. 37, No. 3, 1976, p. 1248-1255.

Research output: Contribution to journalArticle

Frytak, S, Moertel, CG, Schutt, AJ, Ahmann, DL, Donadio, JV & Weinshilboum, RM 1976, 'A phase I study of Cytembena', Cancer, vol. 37, no. 3, pp. 1248-1255. https://doi.org/10.1002/1097-0142(197603)37:3<1248::AID-CNCR2820370304>3.0.CO;2-P
Frytak, S. ; Moertel, C. G. ; Schutt, A. J. ; Ahmann, D. L. ; Donadio, J. V. ; Weinshilboum, Richard M. / A phase I study of Cytembena. In: Cancer. 1976 ; Vol. 37, No. 3. pp. 1248-1255.
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