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New treatment option for Low-grade Glioma
Official title Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas
ClinicalTrials.gov ID: NCT06381570
What this study is testing
What is Tovorafenib?
Tovorafenib is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for low-grade glioma.
Also referred to as Vinblastine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Pilot, multicenter, open-label study of patients less than or equal to 25 years, with recurrent or progressive LGG harboring a CRAF or BRAF alteration, including BRAF V600 mutations and KIAA1549: BRAF fusions. Patients with BRAF or CRAF alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 25
You may be able to join if
- Age a) Patients must be less than or equal to 25 years of age at the time of enrollment.
- Study Group a) Progressive/Recurrent LGG (non-NF1) with documented BRAF or CRAF alteration as identified through molecular assays as routinely...
- Diagnosis
- All patients must have pathological confirmation of low-grade glioma with BRAF or CRAF alteration.
- Patient must have progressive or recurrent LGG.
You likely can't join if
- Patients meeting any of the following criteria are to be excluded from study participation:
- Patient's tumor has additional previously known activating molecular alterations, other than BRAF or CRAF.
- Known or suspected diagnosis of neurofibromatosis Type 1 (NF-1) via genetic testing or current diagnostic clinical criteria.
- History of any major disease, other than the diagnosis of LGG, that might interfere with safe protocol participation.
- Patient with a history or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO), or ophthalmopathy present at baseline...
- Major surgery within 14 days (2 weeks) prior to enrollment (does not include central venous access, cyst fenestration or cyst drainage, or...
See the full eligibility criteria
Who can join
- Age a) Patients must be less than or equal to 25 years of age at the time of enrollment.
- Study Group a) Progressive/Recurrent LGG (non-NF1) with documented BRAF or CRAF alteration as identified through molecular assays as routinely performed at CLIA or other similar certified laboratories.
- Diagnosis
- All patients must have pathological confirmation of low-grade glioma with BRAF or CRAF alteration.
- Patient must have progressive or recurrent LGG.
- Must have at least 1 measurable lesion, as defined by RANO-LGG criteria.
- Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (WHO grade I and II) by WHO classification of Tumors of the Central Nervous system -5th edition revised with exception of...
- Prior Therapy
- Must have received at least 1 line of systemic therapy prior (at least a vinca alkaloid and/or single agent carboplatin and/or a MEK or BRAF inhibitor) and have documented evidence of radiographic progression.
- Patients must have fully recovered from the acute toxic effects (≤ Grade I) of all prior anticancer chemotherapy and have undergone the following washout periods, as applicable. i. Myelosuppressive chemotherapy: At...
- Performance Level a) Karnofsky (those 16 years and older) or Lansky (those younger than 16 years) performance score of at least 50. Patients who are unable to walk because of paralysis, but who are able to sit in a...
- Tumor Tissue Sample Confirmation that an archival tumor tissue sample is available. If an archival tumor tissue sample is not available, a fresh biopsy should be performed at baseline. Submission of tumor tissue and a...
- Organ function a) Adequate bone marrow function defined as: i. Absolute neutrophil count ≥ 1000/mm3 ii. Platelet count (unsupported) ≥ 100 x 109/L (transfusions allowed per institutional guidelines; last transfusion \>...
- Study specific
- Baseline ophthalmology assessment within 28 days of study enrollment.
- MRI assessment within 28 days of study enrollment. MRI done for clinical indication but within the window for study would be permitted as baseline.
- Ability to comply with treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
- Willingness of male and female patients with reproductive potential to use double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for...
- Ability to swallow tablets or liquid, or gastric access via a nasal or gastric tube.
- Patient is able to start treatment within 14 working days of screening.
- Parent/guardian of child or adolescent patient has the ability to understand, agree to, and sign the study ICF and applicable pediatric assent form before initiation of any protocol related procedures; patient has the...
What rules you out
- Patients meeting any of the following criteria are to be excluded from study participation:
- Patient's tumor has additional previously known activating molecular alterations, other than BRAF or CRAF.
- Known or suspected diagnosis of neurofibromatosis Type 1 (NF-1) via genetic testing or current diagnostic clinical criteria.
- History of any major disease, other than the diagnosis of LGG, that might interfere with safe protocol participation.
- Patient with a history or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO), or ophthalmopathy present at baseline who would be considered a risk factor for CSR or RVO. Ophthalmological...
- Major surgery within 14 days (2 weeks) prior to enrollment (does not include central venous access, cyst fenestration or cyst drainage, or ventriculoperitoneal shunt placement or revision).
- Clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to enrollment, ongoing cardiomyopathy, or current prolonged QT...
- Concomitant medications that are strong inhibitors or inducers of CYP2C8 or CYP3A4 within 14 days before initiation of therapy. Concomitant medications that are substrates of BCRP with a narrow therapeutic index within...
- Current enrollment in any other investigational treatment study. Participation on a concurrent observational or bio-sampling study is allowed.
- Active systemic bacterial, viral, or fungal infection.
- Nausea and vomiting ≥ National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Grade 2 (for those not controlled by supportive care), malabsorption requiring supplementation, or...
- Patient has CTCAE v5.0 Grade 3, creatine phosphokinase (CPK) elevation (\> 5 × ULN - 10 × ULN).
- Patients who are neurologically unstable despite adequate treatment (e.g., uncontrolled seizures).
- Pregnancy or lactation.
- History of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome or Stevens Johnsons syndrome (SJS). Patients with hypersensitivity to the investigational medicinal product or to any drug with similar...
- Other unspecified reasons that, in the opinion of the investigator, make the patient unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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, 0 weeks to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.