Bevacizumab and Temozolomide in Treating Older Patients With Newly-Diagnosed Glioblastoma Multifo… (NCT01149850) | Clinical Trial Compass
CompletedPhase 2
Bevacizumab and Temozolomide in Treating Older Patients With Newly-Diagnosed Glioblastoma Multiforme or Gliosarcoma
United States50 participantsStarted 2010-04-28
Plain-language summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as temozolomide, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with temozolomide may be a better way to block tumor growth.
PURPOSE: This phase II trial is studying how well giving bevacizumab and temozolomide together works in treating older patients with newly diagnosed glioblastoma multiforme or gliosarcoma.
Who can participate
Age range70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients will have histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS); this includes treatment-naive patients with prior tissue diagnosis of lower grade gliomas that have been upgraded after repeat resection
* Cranial MRI or contrast CT must have been performed within 21 days of study entry; the use of MRI rather than CT is preferred; the same type of scan, i.e., MRI or CT, must be used throughout the period of protocol treatment for tumor measurement; if the surgical procedure was a resection, cranial MRI or contrast CT performed within 96 hours of resection is preferred, but not required; patients without measureable or assessable disease are eligible
* Patients must begin temozolomide chemotherapy no sooner than 2 weeks and no later than 6 weeks from the diagnostic surgery; patients must begin bevacizumab no sooner than 4 weeks and no later than 6 weeks from the surgery
* Patients must be willing to forego other drug therapy against the tumor while being treated with bevacizumab and temozolomide
* All patients must sign and informed consent approved by the Institutional Review Board indicating that they are aware of the investigational nature of this study; patients must also sign an authorization for the release of their protected heath information
* Life expectancy \> 8 weeks
* Patients must have a Karnofsky performance status of \>= 60
* WBC \>= 3,000/ul
* ANC \>= 1,500/mm\^3
* Platelet count of \>= 100,000/mm\^3
…