Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
Vorinostat in combination with radiation therapy can be administered safely and will be
tolerated in patients with brain metastases, while providing an assessment of the anti-tumor
activity of this combination.
This is a multi-center, open-label, non-randomized Phase I study in patients with brain
metastases. Patients will be administered oral Vorinostat and radiation therapy and will be
treated for 3 weeks. Patients will be enrolled in cohorts and will be treated at sequentially
rising dose levels of Vorinostat combined with radiation therapy. We will initially enter 3
subjects at each dose. If none of the three experiences a dose-limiting toxicity we will
proceed to the next dose. If one of the three experiences that level of toxicity, we will
accrue 3 more subjects at that dose. If at any time there are two or more dose-limiting
toxicities (in the 3-6 subjects) on a given dose, we will drop down to a lower dose. Dose
escalation will continue until the MTD of Vorinostat and radiation therapy is established.
The MTD will then be one dose below the DLT occurring in at least 1 out of 3 subjects (2 out
of 6 patients).
Phase:
Phase 1
Details
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University