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8110 Gatehouse Road, Falls Church, VA 22042

A Phase II trial of SMO/AKT/NF2/CDK inhibitors in progressive meningiomas with SMO/AKT/NF2/CDK pathway mutations (A071401)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT02523014

Background Information

The purpose of this study is to test good and bad effects of four different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO, PTCH1, NF2, AKT1, PIK3CA and PTEN. When these genes are altered, it can cause a tumor to grow. This study will test medications that target these genes.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital

Eligibility Information

  • Adults ages 18 and older (for patients with SMO/PTCH1 mutation: Age ≥ 30 years)
  • Histologically proven intracranial meningioma as documented by central pathology review
  • Progressive or residual measureable disease
  • Molecular Documentation: Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3, or CCNE1 copy number gain in tumor sample
  • Additional eligibility in protocol

Ineligibility Information

  • Chemotherapy, or other investigational agents within 28 days prior to registration
  • Pregnancy/nursing
  • Active hepatitis B or C
  • History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
  • Additional ineligibility in protocol and varies by gene mutation

For additional information, please visit: https://clinicaltrials.gov/ct2/show/NCT02523014