Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioma

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Disease Attributes

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Adult

Diffuse Astrocytoma

Subependymal Giant Cell Astrocytoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Single-arm study with patients receiving Everolimus orally once daily dosing of 10 mg continuously from Day 1 of study until progression of disease or unacceptable toxicity. In addition archival tissue will be analysed for markers of P13K/mTOR pathway activation.

Archival Tissue Analysis

Susan Chang, MD

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

PRIMARY OBJECTIVES:

1. To determine progression-free survival at 6 months associated with use of RAD001 (everolimus) in patients initially diagnosed with low-grade glioma who undergo biopsy or subtotal resection at the time of recurrence with pathologic evidence of recurrent low-grade glioma (LGG).

SECONDARY OBJECTIVES:

1. To further delineate the safety profile of RAD001 in patients with recurrent LGG.
2. To assess overall survival (OS) in patients treated with RAD001.
3. To assess the objective response rate (ORR) in patients treated with RAD001.
4. To assess the correlation of protein kinase B (PKB)/Akt and phosphatase and tensin homolog (PTEN) expression with response, progression status by 6 months, and OS in patients treated with RAD001.

Everolimus in Treating Patients With Recurrent Low-Grade Glioma

Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma

Number of patients alive without progressive disease at 6 months. Assessment of progression was defined by RANO as a 25% increase in the sum of all the products of measurable lesions, clear worsening of any evaluable disease or any new lesion

Grade 4-5 treatment related adverse events as defined by CTCAE 3.0

Objective response is defined as complete or partial response as defined by RANO criteria as determined by MRI and steroid requirement. Complete response was defined by disappearance of all measurable disease with minimal or no steroids; a partial response was defined as 50% in sum of all products in perpendicular diameters of all measurable lesions with no new lesions on stable or decreasing steroids.

Number of years from the day the patient started treatment until the date of death, an average of 5 years.

Survival of patients with p-S6 staining of \>19% (activated pathway)

Novartis

Susan Chang

MD, Professor in Residence

RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.

Daily Intervention With RAD001

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Analysis population is the same as the assigned participant flow.

Grade II

Grade III/IV

RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.

RAD001: RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.

Progression-free Survival at 6 Months.

All patients treated from the time of registration until discontinuation of study drug

RAD001 Safety Profile in Patients With Recurrent LLG

All patients who were treated with study drug

Objective Response Rate (ORR) in Patients Treated With RAD001.

Overall Survival (OS) in Patients Treated With RAD001.

Patients for which the molecular marker PI3K pathway activation was available

To Assess the Correlation of Activation of the PI3K/mTOR Pathway With Survival

Single arm study: RAD001 will be administered orally as once daily dose of 10 mg (two 5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day. RAD001 may be taken with or without food.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Everolimus in Treating Patients With Recurrent Low-Grade Glioma	NCT00823459	Adult Diffuse A... Adult Mixed Gli... Adult Oligodend... Adult Subependy... Recurrent Adult...	Everolimus Archival Tissue...	18 Years -	University of California, San Francisco
Everolimus in Treating Patients With Recurrent Low-Grade Glioma	NCT00823459	Adult Diffuse A... Adult Mixed Gli... Adult Oligodend... Adult Subependy... Recurrent Adult...	Everolimus Archival Tissue...	18 Years -	University of California, San Francisco
Everolimus in Treating Patients With Recurrent Low-Grade Glioma	NCT00823459	Adult Diffuse A... Adult Mixed Gli... Adult Oligodend... Adult Subependy... Recurrent Adult...	Everolimus Archival Tissue...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for archival tissue analysis