OW-GRADE GLIOMA

Phase 1

• Conditions: Children, adolescents and young adults with refractory or recurrent low-grade gliomas; MedDRA version: 21.1Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10038111Term: Recurrent cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10070308Term: Refractory cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003005-10-NL
• Lead Sponsor: Gustave Roussy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-04
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Written informed consent signed by the patient, or parents or legal representative and assent of the minor child where appropriate
2. Age: 6 months to < 21 years of age at time of study entry
3. Diagnosis: one of the three conditions listed below
-Refractory or recurrent low-grade glioma after at least one first-line therapy with pathological documentation in non NF1 patients (no further biopsy is needed at study entry)
-Refractory or recurrent low-grade glioma after at least one first-line therapy in NF1 patients, with or without pathological documentation. For patients with NF1 and optic pathway glioma, no biopsy is required to confirm the radiological diagnosis of the low grade glioma.
-Low grade glioma at diagnosis in NF1 patients when the use of chemotherapy is considered for the treatment in case of threat to vision or unequivocal radiological tumor progression. Pathological documentation is advised but not mandatory.
4. Evaluable Disease on morphologic MRI
5. 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 to disease.
6. Life expectancy = 3 months.
7. Administration of stable dose of steroids for at least one week
8.Adequate organ function
9. Adequate cardiac function:
10.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
11.Possibility of receiving the therapeutic schedule as indicated in the protocol
12.Patients with reproductive potential must use effective /acceptable birth method control (as defined per CTFG guidelines) during their treatment and for up to 90 days after the last dose. F
13.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

Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Concomitant anti-tumor treatment
2.Not recovered to 3.Known intolerance or hypersensitivity to Vinblastine
4.Existence of another severe systemic disease
5.Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines,
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/drug-lists/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 for QTc.
•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)
11. Positive rest for Hepatitis B virus surface antigen

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified