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|NCT01887522 : Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults|
|Ages||Min: 6 Months Max: 20 Years|
1. Written informed consent signed by the patient, or parents or legal representative and
assent of the minor child.
2. Age: 6 months to < 21 years of age at time of study entry
3. Histologically confirmed low-grade glioma in non-NF1 patients (no further biopsy is
needed at study entry). For patients with NF1, no biopsy is required to confirm the
radiological diagnosis of the low grade glioma.
4. Relapse or refractory tumor after at least one first-line therapy, not taking into
account surgery only.
5. Evaluable Disease on morphologic MRI
6. Karnofsky performance status score >=70% for patients >12 years of age, or Lansky
score >=70% for patients <=12 years of age, including patients with motor paresis due
7. Life expectancy >= 3 months.
8. Adequate organ function:
- Adequate hematopoietic function: neutrophils ³1.0 x 109/L, platelets ³100 x
109/L; hemoglobin ³8 g/dL
- Adequate renal function: serum creatinine < 1.5 x ULN for age 0 - 1 year: <= 40
1 - 15 years: <= 65 µmol/L 15 - 20 years: <= 110 µmol/L In case serum creatinine
>1.5 ULN according to age, creatinine clearance has to be >70 mL/min/1.73 m2 or
glomerular filtration rate measurement >70% of the expected value
- Adequate electrolytes levels: potassium, magnesium, phosphor, total calcium Lower
Limit of Normal (LLN)
- Adequate hepatic function: total bilirubin <=1.5 x ULN; AST and ALT <=2.5 x ULN.
- Absence of peripheral neuropathy >= grade 2 (Common Toxicity Criteria Adverse
Event, NCI CTCAE v4.0)
- Adequate cardiac function:
Shortening Fraction (SF) >= 28% (35% for children <3 years) and Left Ventricular
Ejection Fraction (LVEF) >= 50% at baseline, as determined by echocardiography
Absence of QTc prolongation (QTc > 450 msec on baseline ECG, using the QTcF formula)
or other clinically significant ventricular or atrial arrhythmia
9. Wash-out period of at least
- 3 weeks in case of preliminary chemotherapy,
- 6 weeks in case of nitrosourea-containing chemotherapy,
- 2 weeks in the case of treatment with vincristine only
- 6 weeks in case of radiation therapy
10. Possibility of receiving the therapeutic schedule as indicated in the protocol
11. Patients with reproductive potential must use effective contraception during their
treatment and for up to 90 days after the last dose. Females with reproductive
potential must have a negative pregnancy test <= 7 days before starting Nilotinib
12. Patients already treated with one of the two drugs can be enrolled in the trial
provided that rechallenging them with the same drug could be considered acceptable
1. Concomitant anti-tumor treatment
2. Not recovered to immunotherapy or radiotherapy
3. Known intolerance or hypersensitivity to Vinblastine
4. Existence of another severe systemic disease
5. Uncontrolled infections not responsive to antibiotics, antiviral medicines, or
6. Any concurrent illness which in the opinion of the investigator may interfere with the
treatment and evaluation of the patient
7. Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of nilotinib.
8. Simultaneous treatment with strong cytochromes P450 CYP3A4 inhibitors (e.g.
antiepileptic drugs, see complete list in the Appendix 5).
9. Simultaneous treatment with antiarrythmic drugs and other drugs known to prolong QT
interval (cloroquine, halofantrine, clarithromycin, haloperidol, methadone,
moxifloxacin, bepridil, cisapride and pimozide). A list of QT prolonging compounds can
be found at http://www.azcert.org/medical-pros/druglists/drug-lists.cfm (Appendix 6)
10. Impaired cardiac function including any one of the following:
- Clinically significant resting brachycardia (<50 beats per minute).
- QTc > 450 msec on baseline ECG. If QTc >450 msec and electrolytes are not within
normal ranges, electrolytes should be corrected and then the patient re-screened
- Other clinically significant uncontrolled heart disease (e.g. unstable angina,
congestive heart failure or uncontrolled hypertension).
- History of or presence of clinically significant ventricular or atrial
tachyarrhythmias (including congenital long QT syndrome or a known family history
of congenital long QT syndrome)
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