A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT (NCT04897880) | Clinical Trial Compass
TerminatedPhase 2
A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT
Stopped: Drug supply
United States, Australia25 participantsStarted 2019-01-09
Plain-language 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 neuroblastoma.
Who can participate
Age range39 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Patien…
What they're measuring
1
Event free survival
Timeframe: Up to 2 years after study enrolment
2
Overall Survival
Timeframe: Up to 2 years after study enrolment
3
Safety: Adverse events summarised by grade and type
Timeframe: From 1 week to 12 months after intervention commencement
Trial details
NCT IDNCT04897880
SponsorAustralian & New Zealand Children's Haematology/Oncology Group