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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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