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Everolimus With and Without Temozolomide in Adult Low Grade Glioma

NCT02023905 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-12-29

Study results available
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Summary

The purpose of this study is to find out what effects, good and/or bad, everolimus (RAD001, also known as Afinitor®) alone or with temozolomide has on the patient and the patient's low-grade glioma. Everolimus is being investigated as an anticancer agent based on its potential to prevent tumor cells from growing and multiplying. Specifically, there is a protein called mTOR that we think helps many tumors to grow, and everolimus blocks the effect of mTOR. Temozolomide is also an anticancer agent that prevents tumor cells from growing and multiplying.

Conditions

  • Low Grade Glioma
  • World Health Organization (WHO) Grade II Astrocytomas
  • Oligodendrogliomas
  • Mixed Oligoastrocytomas

Interventions

DRUG

Everolimus

everolimus at 10 mg daily continuously

DRUG

Temozolomide

Temozolomide will be dosed initially at 150 mg/m2/day for 5 days out of a 28-day cycle. TMZ will be stopped after 12 cycles

Sponsors & Collaborators

Principal Investigators

  • Jennifer Clarke, MD, MPH · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-19
Primary Completion
2021-09-30
Completion
2021-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02023905 on ClinicalTrials.gov