A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT

Stopped early · Phase 2

Conditions studied: Rhabdoid Tumor, Atypical Teratoid/Rhabdoid Tumor, Malignant Rhabdoid Tumor, Recurrent Brain Tumor, Childhood

In brief

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 neuroblastoma.

Key facts

Study ID

NCT04897880

Run by

Australian & New Zealand Children's Haematology/Oncology Group

People needed

25

Starts

2019-01-09

Expected to finish

2024-05-08

Last updated by the study team

2025-02-24

Who can join

Age: any, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center — Durham, North Carolina, United States
• John Hunter Children's Hospital — New Lambton, New South Wales, Australia
• Sydney Children's Hospital — Randwick, New South Wales, Australia
• The Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Women's and Children's Hospital — North Adelaide, South Australia, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• Monash Children's Hospital — Clayton, Victoria, Australia
• The Royal Children's Hospital — Parkville, Victoria, Australia
• Perth Children's Hospital — Nedlands, Western Australia, Australia
• Starship Children's Hospital — Grafton, Auckland, New Zealand
• Christchurch Hospital — Christchurch, New Zealand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.