Status:
TERMINATED
A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT
Lead Sponsor:
Australian & New Zealand Children's Haematology/Oncology Group
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Secura Bio, Inc.
Conditions:
Rhabdoid Tumor
Atypical Teratoid/Rhabdoid Tumor
Eligibility:
All Genders
Up to 39 years
Phase:
PHASE2
Brief Summary
This trial is evaluating the anti-tumor activity and side effects of panobinostat in treating patients with osteosarcoma, malignant rhabdoid tumor/atypical teratoid rhabdoid tumor (MRT/ATRT), and neur...
Detailed Description
This is an open label, phase II, multi-centre study evaluating the anti-tumor activity of continuous, low dose of panobinostat in patients with recurrent or refractory solid tumors stratified by prima...
Eligibility Criteria
Inclusion
- Patients must be \< 40 years of age.
- Patient must have been histologically diagnosed with osteosarcoma, neuroblastoma or MRT/ATRT at time of diagnosis or relapse. \[osteosarcoma and neuroblastoma arms are closed to recruitment\].
- Patient disease is refractory to conventional therapy, in the case of osteosarcoma, neuroblastoma and MRT/ATRT or there is an absence of effective conventional therapy available in the case of ATRT. Patients must have stable disease (SD) or better following treatment with salvage therapy.
- Karnofsky performance level greater than or equal to 60% for patients 16 years of age and greater, OR Lansky performance levels greater than or equal to 60% for patients less than 16 years of age.
- Life expectancy of greater than 8 weeks.
- Fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy prior to entering study.
- Patients with CNS tumours who are receiving dexamethasone are on a stable/decreasing dose for at least 1 week.
- Adequate BM function
- Adequate renal function
- Adequate liver function
- Adequate cardiac function
- Adequate pulmonary function
- Adequate CNS function - seizure free for at least 2 months
- Adequate serum calcium, magnesium and potassium concentrations
- If female and post-menarchal, pregnancy test must be negative.
- If of reproductive potential, have agreed to use effective contraceptive method.
- If female and lactating, have agreed not to breastfeed.
- Patient and/or their legal guardian have signed a written informed consent form.
Exclusion
- Have received myelosuppressive chemotherapy and/or biologic therapy within 3 weeks (4 weeks if prior nitrosourea).
- Have received local palliative radiotherapy within 2 weeks.
- Have received craniospinal radiotherapy within 3 weeks.
- Have received greater than or equal to 50% radiation of the pelvis within 6 weeks.
- Have received other substantial BM radiation within 6 weeks.
- Have received growth factor(s) within 1 week.
- Are receiving enzyme inducing anticonvulsant therapy.
- Are receiving medications associated with prolongation of QTc interval
- Are receiving hydrochlorothiazide.
- Are receiving metronidazole and/or disulfiram
- Have uncontrolled sepsis.
- Have previously received panobinostat.
- Have symptoms of congestive heart failure, uncontrolled cardiac rhythm disturbance, or a QTc greater than or equal to 450msec.
Key Trial Info
Start Date :
January 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04897880
Start Date
January 9 2019
End Date
May 8 2024
Last Update
February 24 2025
Active Locations (11)
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1
The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center
Durham, North Carolina, United States, 27710
2
John Hunter Children's Hospital
New Lambton, New South Wales, Australia, 2305
3
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
4
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145