phII Study of an HDAC Inhibitor in Very High-risk Relapsed/Refractory Hodgkin's Lymphoma Patients
Status:
Terminated
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open label, phase II study testing ITF2357 in a population of very
high-risk relapsed/refractory Hodgkin's lymphoma patients.
The patients will receive 50 mg ITF2357 four times a day at 6-hour intervals in fed
conditions for 28 consecutive days unless evidence of progressive disease, presence of
unacceptable adverse events or patient's request to discontinue treatment occurs.
Decision regarding the continuation of ITF2357 will be made on:
- the basis of tumor reassessment upon completion of cycle defined as above and not later
than 7 days and
- the occurred toxicity (if any). If complete response or partial response or
stabilization of disease after first cycle, without concomitant relevant toxicities is
observed, the treatment may continue as long as there is no evidence of progressive
disease or appearance of unacceptable adverse events. In any case the treatment shall
not exceed 84 days of drug intake overall (i.e. 12 weeks).
Treatment will be administered on an outpatient basis and patients will be followed regularly
with physical and laboratory tests, as specified in the protocol; in case of hospitalization,
the treatment will be continued or interrupted according to the Investigators' decision.
The study will accrue 23 patients evaluable for efficacy and the anticipated duration of the
study is about 18 months.