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A clinical trial of mithramycin in the treatment of advanced malignant disease.

British Journal of Cancer
Nature Publishing Group
Publication Date
  • Research Article
  • Chemistry
  • Medicine


176 A CLINICAL TRIAL OF MITHRAMYCIN IN THE TREATMENT OF ADVANCED MALIGNANT DISEASE M. BAUM From the Surgical Unit, King's College Hospital Mediccl School, London Received for publication February 23, 1968 MITHRAMYCIN is an antibiotic with cytotoxic activity derived from an actinomycete of the Streptomyces genus. The drug acts like Actinomycin D by inhibiting DNA directed RNA synthesis (Yarbro, Kennedy and Barnum, 1966). There have been several clinical trials of this drug reported by American workers (Parker, Wiltsie, and Jackson, 1960; Spear, 1963; Kofman and Eisenstein, 1963; Hurley, 1965), but so far only 1 trial reported from the United Kingdom (Sewell and Ellis, 1966). Mithramycin appears to have a broad spectrum of activity but to date its importance has only been established in the treatment of testicular neoplasms (Kennedy, Griffen and Lober, 1965; Brown and Kennedy, 1965). Design of trial The present trial was conducted as a phase II investigation of a new anticancer agent according to the methodology of Brindley (1963). In phase I the toxic side effects of a new drug are established and a safe dosage schedule worked out. In phase II a large number of tumour types are screened for any evidence of antitumour activity however minimal. Then phase III trials are undertaken to follow up this evidence in a specific tumour type. For a phase II trial the followving criteria have to be met for each patient entered. A. Incurable cancer which has failed to respond to previous conventional therapy. B. Histological proof of diagnosis. C. One or more of the following for the objective assessment of tumour regression. (i) Palpable tumour masses with well defined margins which can be measured by caliper or ruler. (ii) Multiple lesions that can be counted. (iii) Well defined bony or lung metastases that can be measured on an X-ray. (iv) A tumour-specific biochemical abnormality which can be measured quantitatively. D. At least 1 month since prior treatment by cytotoxic drugs or rad

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