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

Korábbi kezelés

• 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 hydrochlorothiazide.
• Are receiving metronidazole and/or disulfiram
• Have previously received panobinostat.

Laborértékek

• Are receiving medications associated with prolongation of QTc interval
• Have symptoms of congestive heart failure, uncontrolled cardiac rhythm disturbance, or a QTc greater than or equal to 450msec.

Egyéb

• Have uncontrolled sepsis.

• 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.