Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors (NCT01324635) | Clinical Trial Compass
TerminatedPhase 1
Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors
Stopped: Arm A - reached goal; Arm B - poor accrual
United States17 participantsStarted 2012-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient age is \> or = 18 years
✓. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of \< or = 2
✓. Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
✓. Patients must meet the following laboratory criteria:
✓. Clinically euthyroid. Note: Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
✓. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of study treatment. and must be willing to use two methods of contraception one of them being a barrier method during the study and for 3 months after last study drug administration
✓. Pathologic diagnosis and other conditions relating to the different arms of the study:
Exclusion criteria
✕. Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
What they're measuring
1
Maximum tolerated does (MTD) of panobinostat, defined as one level below at which 2 of 6 patients experience a dose-limiting toxicity (DLT)
Timeframe: Up to 30 days after the completion of study treatment
2
Dose-limiting toxicities as defined by the NCI CTCAE version 4.0
Timeframe: Up to 30 days after the completion of study treatment
3
Overall survival
Timeframe: Assessed up to 2 years
4
Progression free survival (PFS)
Timeframe: Assessed up to 2 years
5
Response as defined by RECIST criteria
Timeframe: 8 weeks after completion of study treatment
6
Response as defined by RECIST criteria
Timeframe: Assessed up to 2 years
Trial details
NCT IDNCT01324635
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
✕. Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
✕. Impaired cardiac function including any one of the following:
✕. Uncontrolled hypertension
✕. Concomitant use of drugs with a risk of causing torsades de pointes
✕. Patients with unresolved diarrhea \> or = grade 2
✕. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
✕. Other concurrent severe and/or uncontrolled medical conditions