EUCTR2021-002540-67-FR
Active, not recruiting
Phase 1
Phase 2 trial evaluating metronomic chemotherapy in patients with relapsed or refractory Wilms tumor - MetroWilms-1906
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centre Oscar Lambret
- Enrollment
- 28
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patient \=18 months old and \= 35 years old
- •\- Relapsed or refractory Wilms tumor, histologically proven at diagnosis
- •\- After at least 2 lines of chemotherapy (conventional or high dose, which may include the study molecules) or after 1 line for high risk relapse for which there would not be any curative therapy. If 1 line for high risk relapse, the enrolment should be confirmed by coordinators.
- •\- Radiologically measurable or evaluable disease (visible, target or non\-target\-lesion on MRI or CT\-scan)
- •\- Performance status: Karnofsky performance status (for patients \>16 years of age) or Lansky Play score (for patients \=16 years of age) \= 70%.
- •\- Able to take oral medication or nasal gastric tube or authorized gastrostomy
- •\- Adequate biological criteria:
- •Neutrophils \> 1000/mm3 ; Platelets \> 75 000/mm3
- •Transaminases (ALT/ AST) \= 3 times ULN (or \= 6 times ULN if liver metastasis); total bilirubin \= 2 ULN (except in case of Gilbert’s disease)
- •\- Creatinine \= 1,5 ULN or clearance \= 60 mL/ min/ 1,73m2 (In case of doubt, to be confirm by assessment of cystatin )
Exclusion Criteria
- •\- Prior history of other cancer within 5 years
- •\-Chemotherapy or radiotherapy of target lesion within 3 weeks prior to inclusion
- •\- Target therapy within less than 5 \* half\-life of the substance prior to inclusion
- •\- Major surgery within 15 days prior to inclusion
- •\- Presence of any NCI\-CTCAE v5 grade \= 2 cardiac, hepatic, pulmonary or renal toxicity
- •\- Severe myelosuppression
- •\- Severe peripheral neuropathy (grade \= 2\)
- •\- Fructose intolerance
- •\- Inflammatory bowel chronic disease and/or intestinal obstruction
- •\- Patients with demyelinating form of Charcot\-Marie\-Tooth disease
Outcomes
Primary Outcomes
Not specified
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