Everolimus in Treating Patients With Recurrent or Progressive Low-Grade Glioma

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    University of California, San Francisco
Updated on 7 November 2020

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with recurrent or progressive low-grade glioma.

Description

OBJECTIVES: Primary - To determine the 6-month progression-free survival (PFS) of patients treated with everolimus who were initially diagnosed with low-grade glioma and underwent biopsy or subtotal resection at the time of recurrence with pathologic evidence of recurrent low-grade glioma. Secondary - To further describe the safety profile of this drug in these patients. - To assess overall survival (OS) of patients treated with this drug. - To assess the objective response rate in patients treated with this drug. - To assess the correlation of phosphorylated PKB/Akt and PTEN expression with response, progression status by 6 months, and OS of patients treated with this drug. Tertiary - To determine the 6-month PFS of patients treated with this drug who also underwent prior radiotherapy. OUTLINE: Patients receive oral everolimus once daily. Courses repeat every 8-12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients may continue treatment for as long as benefit is shown. Previously collected tissue samples are analyzed by IHC for phosphorylated PKB/Akt status and PTEN expression for correlation with study endpoints. After completion of study treatment, patients are followed for 30 days.

Details
Condition Brain Tumor
Treatment laboratory biomarker analysis, immunohistochemistry staining method, Everolimus
Clinical Study IdentifierNCT00831324
SponsorUniversity of California, San Francisco
Last Modified on7 November 2020

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note