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8110 Gatehouse Road, Falls Church, VA 22042

Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma (A071601)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT03224767

Background Information

The purpose of this study is to test any good and bad effects of the study drugs called vemurafenib and cobimetinib. Researchers have looked at the genes that can be affected in craniopharyngiomas and have found mutations or changes in the gene called BRAF. When BRAF is altered, it can cause a tumor to grow. Vemurafenib and cobimetinib have already been FDA-approved to treat advanced melanoma. Unlike craniopharyngioma, melanoma is a malignant tumor, however, both melanoma and craniopharyngiomas may have mutations in the gene called BRAF. Both drugs have not been tested in craniopharyngiomas. Because craniopharyngiomas have the same change in the BRAF gene as has been found in melanoma, the purpose of the study is to see if these drugs can shrink craniopharyngiomas. When needed, researchers will also look at a gene called beta-catenin for further confirmations in some cases. Vemurafenib and cobimetinib could shrink your tumor but they could also cause side effects. Researchers hope to learn if the study drugs will shrink the tumor by at least one-quarter compared to its present size.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Adults over the ages of 18
  • Participants must have local diagnosis of papillary craniopharyngioma with positive BRAF V600E mutation
  • No prior treatment with BRAF or MEK inhibitors
  • Participants 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
  • No symptomatic congestive heart failure (New York Heart Association Class II, III, or IV) within 6 months prior to registration
  • No current unstable angina or uncontrolled arrhythmia
  • Additional eligibility in protocol and depending on cohort recommendation

Ineligibility Information

  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required
  • No evidence of active bleeding, bleeding diathesis, or hemoptysis (≥ ½ teaspoon of red blood) ≤ 8 weeks prior to registration
  • No evidence of intracranial hemorrhage ≤ 4 weeks prior to registration
  • Chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors is not allowed. Patients must discontinue the drug at least 14 days prior to study registration
  • Chronic concomitant treatment with CYP1A2 substrate is not allowed. Patients must discontinue the drug at least 14 days prior to study registration
  • Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT03224767