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A071601


Title

Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas

Therapeutic Area Craniopharyngioma
Principal Investigator Suriya Jeyapalan
Min Age 18 Years
Gender Male or Female
Contact NCCCR
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03224767?term=A071601&draw=2&rank=1

Overview

This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Inclusion Criteria

    • Absolute Neutrophil count ≥ 1500/mm3

 

    • Platelets ≥ 100,000/mm3

 

    • Creatinine ≤ 1.5 mg/dL OR Creatinine Clearance 45mL/min

Exclusion Criteria

  • No evidence of active bleeding, bleeding diathesis, or hemoptysis (>= 1/2 teaspoon of red blood) =< 8 weeks prior to registration

  • No evidence of intracranial hemorrhage =< 4 weeks prior to registration

  • Patients who have experienced thromboembolic event within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 4 weeks prior to registration

Study Requirements

Vemurafenib taken two times a day for 28 days. Cobimetinib taken for 21 days.

Electrocardiograms (EKG) will be performed at screening and every month for 3 months, then every 3 months while receiving vemurafenib.

Echocardiograms (Echo) of the heart (or MUGA) will be performed at screening and after 1 month of treatment and every 3 months while on cobimetinib.

Brain MRI at screening and every 8 weeks during study treatment, then every 16 weeks after completion of study treatment.

An eye exam is needed every 2 months for one year, then every 6 months while on study drugs, and at the end of treatment with study drugs.