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Phase 1 study of a Propranolol (HEMANGIOL®) and oral metronomic Vinorelbine (NAVELBINE®) combination on children and teenagers With Refractory/Relapsing Solid Tumors - PROVIN
EU CTIS ID: 2024-517185-42-00
What this study is testing
To determine the maximal tolerated dose of oral navelbine given 3 times a week with daily oral propanolol
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histological diagnosis of malignancy or typical radiological appearance of a low-grade glial tumor not warranting biopsy or surgery, and desmoid tumors
- No known allergy to any of the compounds in the experimental treatment
- Able to swallow softgels and oral suspension or tablets
- Life expectancy > 3 months
- Affiliation to a social security scheme
- Effective contraception (if applicable) throughout the treatment period. Women of childbearing potential must use effective contraception during treatment, and at least until 7 months after treatment. Men treated with Navelbine must be warned not to conceive a child during treatment, and must use effective contraception during treatment and at least until 4 months after treatment.
You likely can't join if
- Chemotherapy within 21 days prior to D1 of the start of study treatment. This period may be shortened in the case of vincristine treatment (2 weeks) and extended to 6 weeks in the case of nitrosourea treatment or 5 half-lives in the case of targeted therapies or metronomic chemotherapy.
- Contraindications to navelbine: pathologies affecting absorption of the treatment, notably a history of surgical resection of the stomach, patients on long-term oxygen therapy, vaccination against yellow fever
- Inflammatory bowel disease
- Pregnant or breast-feeding women
- Organ toxicity grade > 2 according to NCI-CTCAE scale version 5.0
- Active infection
See the full eligibility criteria
Who can join
- Histological diagnosis of malignancy or typical radiological appearance of a low-grade glial tumor not warranting biopsy or surgery, and desmoid tumors
- No known allergy to any of the compounds in the experimental treatment
- Able to swallow softgels and oral suspension or tablets
- Life expectancy > 3 months
- Affiliation to a social security scheme
- Effective contraception (if applicable) throughout the treatment period. Women of childbearing potential must use effective contraception during treatment, and at least until 7 months after treatment. Men treated with Navelbine must be warned not to conceive a child during treatment, and must use effective contraception during treatment and at least until 4 months after treatment.
- Having signed the informed consent form. For unemancipated minors, authorization will be given by the holders of parental authority. Minors will receive information adapted to their ability to understand.
- Refractory or relapsed disease, in therapeutic failure despite standard treatments, or for which there is no effective standard therapy
- Measurable lesions according to RECIST, INSS or WHO criteria depending on histological type
- Age > or = 4 years and <24 years
- Lansky score >50 or Karnofsky>50
- Hematological conditions: neutrophils > 1 x 109/l and platelets > 75 x 109/l
- Creatinine < 1.5 x upper limit of normal for age (ULN) or Schwarz clearance > 70 ml/ mn/1.73 m2
- Liver function: Total Bilirubin < 1.5 LNS and SGOT and SGPT <3 LNS except in the case of liver metastases: Total Bilirubin < 3LNS and SGOT and SGPT <5 LNS
- Absence of other organ toxicity (Grade < 2 according to NCI-CTC v5.0)
What rules you out
- Chemotherapy within 21 days prior to D1 of the start of study treatment. This period may be shortened in the case of vincristine treatment (2 weeks) and extended to 6 weeks in the case of nitrosourea treatment or 5 half-lives in the case of targeted therapies or metronomic chemotherapy.
- Contraindications to navelbine: pathologies affecting absorption of the treatment, notably a history of surgical resection of the stomach, patients on long-term oxygen therapy, vaccination against yellow fever
- Inflammatory bowel disease
- Pregnant or breast-feeding women
- Organ toxicity grade > 2 according to NCI-CTCAE scale version 5.0
- Active infection
- Inability to undergo medical follow-up for geographical, social or psychological reasons
- Radiotherapy within 3 months prior to D1 of the start of study treatment. RT on a non-target lesion is permitted up to 3 weeks before inclusion.
- Previous treatment with oral or IV vinorelbine in a metronomic regimen
- High blood pressure during treatment.
- None hypersensibility to any of the investigational drugs, including their respective excipients
- Contraindications to propranolol (asthma or history of bronchospasm, Prinzmetal's angina, severe peripheral arterial disorders, Raynaud's syndrome, arterial hypotension (age-dependent limits), second- or 3rd-degree AVB, sinus disease including sino-auricular block, bradycardia with age-dependent limits, cardiogenic shock, heart failure not controlled by treatment, diabetes/predisposition to hypoglycemia, untreated pheochromocytoma, chronic obstructive bronchitis, history of anaphylactic reaction, as part of primary and secondary prevention of digestive bleeding in cirrhotics: advanced liver failure with hyperbilirubinemia, massive ascites, hepatic encephalopathy)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.