Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy. Italian Study Group for the Di Bella Multitherapy Trails.

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 8 different 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 1998 and followed to 31 October 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 3 months, 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: 1 of the 32 patients with non-Hodgkin's lymphoma; 1 of the 33 patients with breast cancer; and 1 of the 29 patients 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.

SUBMITTER:  

PROVIDER: S-EPMC27702 | biostudies-literature | 1999 Jan

REPOSITORIES: biostudies-literature