Everolimus in Treating Patients With Recurrent Low-Grade Glioma

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Adult Diffuse Astrocytoma
Adult Mixed Glioma
Adult Oligodendroglioma
Adult Subependymal Giant Cell Astrocytoma
Astrocytoma
Brain Neoplasms
Glioma
Oligodendroglioma
Recurrent Adult Brain Neoplasm

Clinical Trial Details

NCT number	NCT00823459
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Completed
Phase	Phase 2
Start date	January 23, 2009
Completion date	November 13, 2017

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02194452` - Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors	N/A
Completed	`NCT01417507` - Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery	N/A
Completed	`NCT01977677` - Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma	Phase 1/Phase 2
Completed	`NCT01648348` - Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme	Phase 1/Phase 2
Completed	`NCT01119599` - RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma	Phase 1
Terminated	`NCT01103375` - Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma	Phase 1
Completed	`NCT01131234` - Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors	Phase 1
Terminated	`NCT01378481` - High-Dose Vorinostat and Fractionated Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Glioma	Phase 1
Terminated	`NCT01148966` - Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors	Phase 1
Completed	`NCT00499473` - Sunitinib in Treating Patients With Recurrent Malignant Gliomas	Phase 2
Completed	`NCT00492089` - Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer	Phase 2
Terminated	`NCT00110032` - Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors	Phase 1
Completed	`NCT00049127` - Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor	Phase 1/Phase 2
Active, not recruiting	`NCT01165632` - Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma	Early Phase 1
Terminated	`NCT01269411` - RO4929097 in Treating Patients With Recurrent Invasive Gliomas	Phase 1
Completed	`NCT00650923` - Aflibercept, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma Multiforme, Gliosarcoma, or Other Malignant Glioma	Phase 1
Terminated	`NCT00430079` - Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma	N/A
Completed	`NCT02186509` - Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas	Phase 1
Completed	`NCT01051557` - Temsirolimus and Perifosine in Treating Patients With Recurrent or Progressive Malignant Glioma	Phase 1/Phase 2
Completed	`NCT00085540` - FR901228 in Treating Patients With Recurrent High-Grade Gliomas	Phase 1/Phase 2