A Panobinostat Presurgery
| Status: | Archived |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2010 |
| End Date: | April 2012 |
Phase II Study of Panobinostat (LBH589) for Recurrent Glioblastoma (GBM) Undergoing Planned Surgical Resection
In the current study, the investigators will evaluate intratumoral pharmacodynamic and
pharmacokinetic data associated with the administration of the HDACI, Panobinostat, among
recurrent GBM patients. In addition, this study will evaluate the safety and tolerability of
this agent, as well as evidence of anti-tumor activity in the patient population.
This study will enroll a maximum of 24 subjects with recurrent GBM who are scheduled for
planned debulking craniotomy.
After screening and enrollment on the study, subjects will receive 20mg panobinostat 3 times
a week for one week prior to surgery. Within 2-6 weeks of resection, subjects will resume
panobinostat at 20mg panobinostat 3 times per week.
The primary endpoint will be 6-month progression-free survival. Each cycle of therapy will
be 28 days. All subjects will be assessed after every other cycle of therapy. Subjects will
remain on study therapy for at least one year unless they develop progressive disease,
unacceptable toxicity, non-compliance with study procedures or withdraw consent. Patients
may continue treatment with oral panobinostat until they experience unacceptable toxicity
that precludes further treatment, disease progression, and/or at the discretion of the
investigator.
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