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New treatment option for High Grade Glioma
Official title A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion
ClinicalTrials.gov ID: NCT04655404
What this study is testing
What is Larotrectinib?
Larotrectinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for high grade glioma.
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 study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given.
- 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 up to 21
You may be able to join if
- Age: Patients ≤ 21 years of age (birth to 21 years of age) at the time of study enrollment will be eligible.
- Diagnosis: Patients with newly-diagnosed high-grade (HGG), including diffuse intrinsic pontine gliomas (DIPG), whose tumors are documented in a...
- Disease Status: Patients with disseminated DIPG or HGG are eligible only if the patient is to receive chemotherapy only, i.e. no craniospinal RT is...
- Surgical Cohort ONLY: Patients with newly-diagnosed HGG with NTRK fusions who have undergone prior biopsy and for whom further resection is indicated...
- Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (See Appendix I). Patients who are...
You likely can't join if
- Organ Function Requirements: Adequate Bone Marrow Function Defined as: Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3 Platelet count ≥...
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown risks of fetal and teratogenic adverse...
- Concomitant Medications Investigational Drugs: Patients who have previously received or are currently receiving another investigational drug are not...
- Infection: Patients must not have any active, uncontrolled systemic bacterial, viral or fungal infection.
- Patients who have received prior solid organ transplantation are not eligible.
- Patients must not have malabsorption syndrome or other condition affecting oral absorption.
See the full eligibility criteria
- Age: Patients ≤ 21 years of age (birth to 21 years of age) at the time of study enrollment will be eligible.
- Diagnosis: Patients with newly-diagnosed high-grade (HGG), including diffuse intrinsic pontine gliomas (DIPG), whose tumors are documented in a CLIA/CAP certified lab (or clinically equivalent method considered standard...
- Disease Status: Patients with disseminated DIPG or HGG are eligible only if the patient is to receive chemotherapy only, i.e. no craniospinal RT is intended to be given. MRI of spine must be performed if disseminated...
- Surgical Cohort ONLY: Patients with newly-diagnosed HGG with NTRK fusions who have undergone prior biopsy and for whom further resection is indicated for a more definitive surgery at an enrolling site will be eligible...
- Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (See Appendix I). Patients who are unable to walk because of paralysis, but who are up in a wheelchair...
- Prior Therapy: Patients must not have received any prior anti-cancer chemotherapy. Prior use of corticosteroids are allowed (see below
- Organ Function Requirements: Adequate Bone Marrow Function Defined as: Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3 Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet...
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be...
- Concomitant Medications Investigational Drugs: Patients who have previously received or are currently receiving another investigational drug are not eligible. Anti-cancer Agents: Patients who have previously received or...
- Infection: Patients must not have any active, uncontrolled systemic bacterial, viral or fungal infection.
- Patients who have received prior solid organ transplantation are not eligible.
- Patients must not have malabsorption syndrome or other condition affecting oral absorption.
- Patients must not be receiving any treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer. (See Appendix III.) Strong inducers or inhibitors of CYP3A4 should be avoided from 7 days prior to enrollment...
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Randwick, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Perth, Western Australia, Australia
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Heidelberg, Baden-Wurttemberg, Germany
- Augsburg, Germany
- Berlin, Germany
- Cologne, Germany
- Göttingen, Germany
+ 1 more site(s).
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, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Durham, North Carolina, United States; Cincinnati, Ohio, United States and 15 more location(s). 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.