Clinical trial · Interventional
Study of Everolimus (RAD001) in Patients With Recurrent Glioblastoma Multiforme (GBM)
A Phase II Trial of RAD001 in Patients With Recurrent Glioblastoma Multiforme
NCT00515086CI-TRIAL-00005528terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early termination due to slow enrollment and protocol-defined stopping rule.
Summary
Brief summary (as posted)
This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- No Surgery (Everolimus 10 mg)
- description
- Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
- interventionNames
- Drug: Everolimus
- type
- EXPERIMENTAL
- label
- Everolimus 10 mg + Surgery
- description
- Participants scheduled to undergo salvage surgical resection received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
- interventionNames
- Drug: Everolimus
- Procedure: Surgery
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.