Status:
NOT_YET_RECRUITING
Axitinib and Oral Metronomic Etoposide for Pediatric Children and AYA Refractory/Relapsing Medulloblastoma and Ependymoma
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Medulloblastoma
Ependymoma
Eligibility:
All Genders
4-25 years
Phase:
PHASE1
PHASE2
Brief Summary
It is an open multicentric phase I/II trial with axitinib (Inlyta®) and metronomic delivery of etoposide for children, adolescent and young adults (AYA) with refractory/ relapsing solid tumors. It is ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically proven diagnosis of ependymoma or medulloblastoma
- Methyloma classification performed or available material for methyloma analysis
- Confirmed progressive or refractory disease despite standard therapy, or for which no effective standard therapy exists
- Male and female subjects with \> 4 to ≤ 25 years of age at inclusion
- Weight \> 20 kg
- Evaluable target lesion(s) according to RAPNO
- Performance status: Karnofsky performance status (for patients \>12 years of age) or Lansky Play score (for patients ≤12 years of age) ≥ 70%. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- Life expectancy ≥ 3 months
- No known allergy to any of the compounds in the experimental treatment
- Able to take oral treatments
- Adequate organ function:
- Hematologic criteria
- Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3 (unsupported)
- Platelet count ≥ 100,000/mm3 (unsupported)
- Hemoglobin ≥ 8.0 g/dL (transfusion is allowed) Cardiac function
- Shortening fraction (SF) \>29% and left ventricular ejection fraction (LVEF) ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy).
- Renal and hepatic function
- Serum creatinine \< 1.5 x upper limit of normal (ULN) for age
- Total bilirubin \< 1.5 x ULN
- Alanine aminotransferase (ALT)/ Aspartate aminotransferase (AST)/ \< 2.5 x ULN
- Able to comply with scheduled follow-up and with management of toxicity.
- Females of child bearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment.
- Sexually active patients must agree to use adequate and appropriate contraception (in accordance with Clinical Trials Facilitation and Coordination Group (CTFG) recommendations) while on study drug and for 6 months after stopping the study drug.
- Patient able to comfortably swallow capsules.
- Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.
- Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
- Non-inclusion Criteria
- Chemotherapy within 21 days of day 1 from the start of study treatment. This period can be shortened in the case of treatment with vincristine (2 weeks) and extended to 6 weeks in the case of treatment with nitrosureas. The period is set to 5 half-lives in the case of targeted therapies or metronomic chemotherapy. The period is set to 2 weeks after bevacizumab administration. Evidence of \> Grade 1 recent CNS hemorrhage on the baseline MRI or scan.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).
- Known active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- Presence of any NCI-CTCAE v5 grade ≥ 2 treatment-related extra-hematological toxicity with the exception of alopecia, ototoxicity or peripheral neuropathy.
- Known congenital immunodeficiency.
- Radiotherapy within the 2 months preceding D1 of the start of study treatment. Palliative RT on a non-target lesion is allowed up to 1 weeks before beginning of treatment.
- Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered.
- Bleeding disorder.
- Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).
- Known hypersensitivity to any study drug or component of the formulation.
- Absence of effective contraception in patients of childbearing age (see appendix 3)
- Pregnant or nursing (lactating) females.
- Patients with galactose intolerance, lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
- Severe infections requiring parenteral antibiotic therapy.
- Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons.
Exclusion
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06485908
Start Date
October 1 2024
End Date
January 1 2030
Last Update
July 3 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.