Ten patients (variable: n1) are entered into the study in the first stage of the trial. Their outcome will be evaluated after six months of experimental therapy. If there will be fewer than 10% of good responses (variable: P0), then accrual will terminate and the drug will be rejected as being of little interest. Otherwise, accrual will continue to a total of 30 patients (variable: n). All patients will undergo the same experimental treatment and outcome evaluation. At the end of the study the drug will be rejected if the observed response rate will be less than 30% (variable: P1) of evaluable patients.