A Phase I Study of LBH589 in Children With Refractory Solid and Central Nervous System (CNS) Tumours
- Conditions
- Relapsed/refractory solid tumours including CNS tumoursCancer - Children's - BrainCancer - Children's - Other
- Registration Number
- ACTRN12609000978268
- Lead Sponsor
- Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
* 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.
* Adequate Liver function tested within 1 week of registration – total bilirubin <=1.5 x Institutional Upper Limit of Normal (IULN) for age, serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase(ALT)) <=5 x IULN for age, and albumin >= 2g/dL (20g/L).
* Adequate Cardiac Function tested within 2 weeks of registration – shortening fraction of > 27% by echocardiogram OR ejection fraction of >= 50% by gated radionuclide study
* Adequate Pulmonary function tested within 2 weeks of registration with no evidence of dyspnoea at rest, no exercise intolerance and pulse oximetry (SaO2) >94%
* Adequate CNS function – seizure free for 2 months prior to study entry
* Adequate serum calcium, magnesium and potassium concentrations tested within 1 week of registration – all must be >= Institutional Lower Limit of Normal (ILLN) for age with or without supplementation.
* If female and postmenarchal, 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 guardians have signed a written informed consent form
* 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.
* Are receiving Metronidazole and/or Disulfiram
* Have uncontrolled Sepsis.
* Have previously received LBH589.
* Have symptoms of congestive heart failure, uncontrolled cardiac rhythm disturbance, or a QTc >= 450msec.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method