Phase 2 trial evaluating metronomic chemotherapy in patients with relapsed or refractory Wilms tumor
- Conditions
- Wilms tumorMedDRA version: 20.0Level: PTClassification code 10029145Term: NephroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002540-67-FR
- Lead Sponsor
- Centre Oscar Lambret
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
- 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 )
- Females of childbearing potential must have a negative seric pregnancy test within 7 days prior to initiation of treatment.
- Sexually active patients must agree to use adequate and appropriate contraception (at least one highly effective contraception or two complementary methods of contraception), 1 month before beginning of treatment while on study drug and for 6 months after stopping the study drug for both female and male patients.
- Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures according to national guidelines.
- Patient covered by the French Social Security” regime.
Are the trial subjects under 18? yes
Number of subjects for this age range: 22
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
- Known active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- Known hypersensitivity to dacarbazine (DTIC), isotretinoin or to any of the study drugs, study drug classes, excipients in the formulation
- Hyperlipidemia and hypervitaminosis A
- Vaccination with a live attenuated vaccine within 1 month prior to inclusion
- Pregnant or breastfeeding patients
- Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method