Quality-of-Life Assessment for Papillary Craniopharyngioma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Papillary Craniopharyngioma+3 More
Quality-of-Life Assessment - Other
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

1 of 3

Other trials for Papillary Craniopharyngioma

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

2 of 3
This is further along than 68% of similar trials

Other trials for Papillary Craniopharyngioma

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 preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

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.