Glioblastoma Multiforme Clinical Trial
Official title:
A Phase II Trial of RAD001 in Patients With Recurrent Glioblastoma Multiforme
Verified date | September 2011 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM)
Status | Terminated |
Enrollment | 41 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 years of age or older - Histologically confirmed Glioblastoma Multiforme (GBM) - Radiographic evidence of disease progression - Patients must have evaluable contrast enhancing tumor - Availability of paraffin blocks or unstained pathology slides for biomarker studies - Karnofsky Performance Status of greater than or equal to 60% Exclusion Criteria: - Prior treatment with Mammalian target of rapamycin (mTOR) inhibitor - History of another malignancy within 3 years - Cardiac pacemaker - Ferromagnetic metal implants other than those approves as safe for use in Magnetic resonance imaging (MRI) scanners - Claustrophobia - Obesity - Unstable systemic diseases - Elevated cholesterol or triglycerides - Radiation therapy or cytotoxic chemotherapy <=4 weeks prior to study enrollment. Patient must have recovered from the toxic effects of a prior chemotherapy. - Patients must be off all enzyme inducing anticonvulsants for at least 2 week before study enrollment can occur - Need for increasing dose of steroids. Patients on a stable or tapering dose of steroids >=7 days were permitted. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Northwestern University | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Duke University - Preston Robert Tisch Brain Tumor Center | Durham | North Carolina |
United States | UCLA | Los Angeles | California |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels | In the Surgery Group, the primary efficacy assessment was inhibition of Mammalian target of rapamycin (mTOR) as defined as =75% S6 phosphorylation. The occurrence of S6 phosphorylation was determined by phosphor-S6 immunohistochemical staining. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. | Baseline and Day 7-9 (during salvage surgery) | No |
Primary | No Surgery Group: Best Overall Tumor Response | The best overall tumor response is reported for participants with 1 previous relapse and participants with =2 previous relapses according to the following categories: Complete Response, Partial Response, Stable Disease and Progressive Disease. Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) was used for tumor analysis. The objective assessment of tumor response was evaluated at each site by the designated pathologist based on the Neuro-Oncology criteria for Tumor Response for Central Nervous System (CNS) tumors. | First day of treatment to study discontinuation (up to 60 weeks) | No |
Secondary | Surgery Group: Blood and Brain Tissue Levels of Everolimus (RAD001) | Baseline and Day 7-9 (Blood samples were collected one day prior to surgery and tissue samples were collected during surgery.) | No | |
Secondary | Surgery Group: Progression-free Survival | Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS was measured from the first day of treatment after surgery to disease progression or death and is derived using the Kaplan-Meier method. | After surgery (within 96 hours), Weeks 4 and 8 and then every 8 weeks after restarting treatment until study discontinuation (Up to 28 weeks) | No |
Secondary | Surgery Group: Biomarkers Phosphatase and Tensin Homolog (PTEN) and Epidermal Growth Factor Receptor (EGFR) | The secondary efficacy assessment was to evaluate the role of PTEN and EGFR pathway status on phosphor-S6. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. Immunohistochemistry and Fluorescence in-situ hybridization (FISH) were used to assess PTEN and EGFR pathway status. Study was terminated due to slow enrollment. Analysis was not possible due to insufficient sample size. |
After surgery, week 4, week 8 and every 8 weeks thereafter | No |
Secondary | No Surgery Group: Progression Free Survival | Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS is reported for participants with 1 previous relapse and participants with =2 previous relapses. PFS was measured from the first day of treatment to disease progression or death and is derived using the Kaplan-Meier method. | First day of treatment to study discontinuation (up to 60 weeks) | No |
Secondary | Surgery Group: Number of Participants With Adverse Events | The number of participants with any adverse event by System Organ Class. Additional information about Adverse Events can be found in the Adverse Event Section. | First day of treatment to study discontinuation (Up to 28 weeks) | No |
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