Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy

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Abstract
Objective: To determine whether the treatment known as Di Bella multitherapy exerts antitumour activity worthy of further controlled clinical evaluation. Design: 11 independent multicentre uncontrolled phase II trials relevant to 8different types of cancer. Setting: 26 Italian hospitals specialising in cancer treatment. Subjects: 386 patients with advanced cancer were enrolled in the trials between March and July 1998and followed to 31October 1998. Interventions: Melatonin, bromocriptine, either somatostatin or octreotide, and retinoid solution, the drugs that constitute Di Bella multitherapy, were given to patients daily. Cyclophosphamide and hydroxyurea were added in some trials. Main outcome measures: Responses were assessed every 1,2,or 3months, depending on the specific trial, and toxicity was evaluated using criteria developed by the World Health Organisation. Results: No patient showed complete remission. Three patients showed partial remission: 1of the 32patients with non-Hodgkin's lymphoma; 1of the 33patients with breast cancer; and 1of the 29patients with pancreatic cancer. At the second examination, 12% (47) of the patients had stable disease; 52% (199) progressed; and 25% (97) died. Conclusions: Di Bella multitherapy did not show sufficient efficacy in patients with advanced cancer to warrant further clinical testing.

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