Quality-of-Life Assessment for Papillary Craniopharyngioma
Phase-Based Progress Estimates
Effectiveness
Safety
Papillary Craniopharyngioma+3 More
Quality-of-Life Assessment - OtherEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial tests vemurafenib and cobimetinib to treat patients with a certain type of brain tumor. The drugs may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligible Conditions
- Papillary Craniopharyngioma
- BRAF V600E Mutation Present
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Up to 5 years
Up to 5 years
Overall survival
Progression-free survival
Response rate
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Treatment (vemurafenib, cobimetinib)
1 of 1
Experimental Treatment
36 Total Participants · 1 Treatment Group
Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 2
Treatment (vemurafenib, cobimetinib)Experimental Group · 4 Interventions: Laboratory Biomarker Analysis, Quality-of-Life Assessment, Cobimetinib, Vemurafenib · Intervention Types: Other, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
FDA approved
Vemurafenib
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
12,991 Previous Clinical Trials
41,298,457 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
497 Previous Clinical Trials
214,640 Total Patients Enrolled
Priscilla K. Brastianos, MDStudy ChairMassachusetts General Hospital
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a papillary craniopharyngioma with BRAF V600E mutation by IHC.
Measurable disease, defined as bidimensionally measurable lesions with clearly defined margins by magnetic resonance imaging (MRI) scans, with a minimum diameter of 10 mm in both dimensions.
Cohort B: Radiation therapy prior to surgery is allowed.
Recovered to CTCAE grade 1 or less toxicity attributed to radiation with exception of alopecia, fatigue.
For patients treated with external beam radiation therapy, interstitial brachytherapy or radiosurgery, an interval of > 3 months must have elapsed from completion of radiation therapy to registration.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Rutenberg, Michael S., Ronny L. Rotondo, Dinesh Rao, Adam L. Holtzman, Daniel J. Indelicato, Soon Huh, Christopher G. Morris, and William M. Mendenhall. 2020. “Clinical Outcomes Following Proton Therapy for Adult Craniopharyngioma: A Single-institution Cohort Study”. Journal of Neuro-oncology. Springer Science and Business Media LLC. doi:10.1007/s11060-020-03432-9.
- 2017. "Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03224767.
Top Oncology Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments