A Phase I Study to determine the Maximum Tolerated Dose (MTD) of LBH589 in Paediatric Patients With Refractory Solid Tumours Including Central Nervous System (CNS) Tumours

Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)0 sites52 target enrollmentNovember 12, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)
Enrollment: 52
Status: Completed
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

November 12, 2009

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)

•\* Patients must be \< 18 years of age.
•\* Patient must have been histologically diagnosed with refractory solid tumours (including CNS) at time of diagnosis or relapse.
•\* Patient disease is refractory to conventional therapy or absence of conventional therapy available.
•\* Karnosfsky performance level of \>\=60% for patients \> 10yr of age, OR Lansky performance levels \>\=60% for patients \<\=10yr of age.
•\* Life expectancy of \>\= 8 weeks.
•\* Fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy prior to entering study.
•\* Fully recovered (ie. No evidence of graft versus host disease) from stem cell transplant (SCT).
•\* Patients with CNS tumours who are receiving dexamethasone are on a stable/decreasing dose for at least 1 week.
•\* Adequate bone marrow (BM) function tested within 1 week of registration – peripheral blood absolute neutrophil count (ANC) \> 1000/ul (or 1 x 109/mL); Platelet \> 100 000/ul (or 100 x 109/mL); haemoglobin \> 8gm/dL (or \>80 g/L).
•\* Adequate Renal function tested within 1 week of registration – age\-adjusted normal serum creatinine or glomerular filtration rate (GFR) \>70ml/min/1\.73m2\.

•\* Have received myelosuppressive chemotherapy and/or biologic therapy within 3 weeks (4 weeks if prior nitrosourea).
•\* Have received local palliative radiotherapy (small port) within 2 weeks.
•\* Have received craniospinal radiotherapy within 3 months.
•\* Have received \>50% radiation of the pelvis within 3 months.
•\* Have received other substantial BM radiation within 6 weeks.
•\* Have received allogeneic stem cell transplant within 6 months.
•\* 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 while on study.