Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive I… (NCT00972335) | Clinical Trial Compass
TerminatedPhase 2
Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma
Stopped: Study terminated early due to slow accrual
United States18 participantsStarted 2010-01
Plain-language summary
In this multicenter, Phase II trial, the investigators plan to evaluate the activity of the combination of bevacizumab and everolimus in patients with recurrent, progressive meningioma following maximal treatment with surgical resection and local radiation therapy. Although these patients are relatively rare, there is currently no established standard of treatment for a disease that causes a great deal of morbidity, and that is eventually fatal.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must be 18 years of age.
✓. Histologic diagnosis of meningioma, WHO grade 1, 2, or 3 (benign, atypical, or malignant). In addition, patients with definitive radiologic evidence of meningioma who are unresectable, and in whom radiation therapy without biopsy is the standard treatment, are also eligible.
✓. All patients must have developed recurrent disease/progression after receiving all standard treatments, which must include the following:
✓. All patients must have progressive symptoms judged to be directly related to their recurrent/progressive meningioma. Patients with no new symptoms, or patients with stable neurologic deficits from previous surgical resection, are not eligible.
✓. Patients may have had 0 or 1 previous systemic treatment regimens.
✓. ECOG performance status of 0-2.
✓. Adequate bone marrow, kidney, and liver function, as follows:
✓. Life expectancy of at least 12 weeks.
Exclusion criteria
What they're measuring
1
Progression-free Survival (PFS), in the Treatment of Patients With Refractory Meningioma.
. Previous treatment with bevacizumab or any other anti-angiogenesis agents.
✕. Previous treatment with m-TOR inhibitors (sirolimus, temsirolimus, everolimus).
✕. Patients who have had major surgery or significant traumatic injury within 4 weeks of the start of study drugs, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study.
✕. Minor surgical procedures (with the exception of the placement of portacath or other central venous access) must be completed at least 7 days prior to beginning protocol treatment.
✕. Women who are pregnant or lactating.
✕. Patients with proteinuria at screening as demonstrated by either:
✕. Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
✕. Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).