Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors
Status:
Terminated
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
This is an open label phase I clinical trial with two arms, representing single and
fractionated radiation therapy (Figure 4.1). Within each arm the radiation dose is
pre-determined and not escalated. Panobinostat will be administered orally 3 times a week for
2 weeks. Panobinostat will be dose-escalated independently in each arm. There is no
intra-patient dose escalation.
Recurrent gliomas (Arm A) will be treated according to the Jefferson protocol for
re-irradiation, 10 fractions each of 3.5Gy delivered over 2 weeks. Panobinostat will be
administered orally three times a week for 2 weeks, starting on day 1 or 2 of radiation
therapy. High-grade meningiomas (Arm A) will be treated with 6 weeks/30 fractions of
fractionated radiation therapy, to a total dose of between 54 Gy and 60 Gy in fractions of
either 1.8Gy or 2Gy. Panobinostat will be administered orally three times a week for 2 weeks,
starting on the day of 1st fraction of radiation.
Large brain metastases (Arm B) will be treated with a single fraction of radiosurgery.
Panobinostat will be administered orally three times a week for 2 weeks, starting on the day
of radiation. The radiosurgery may be delivered by either LINAC, gamma-knife, cyber-knife or
tomotherapy technology.
Phase:
Phase 1
Details
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University