Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuva… (NCT02717962) | Clinical Trial Compass
CompletedPhase 2
Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuvant or Recurrent Setting
United States118 participantsStarted 2017-01-20
Plain-language summary
The purpose of this phase 2, two arm, biomarker-driven study is to determine if treatment of O-6-methylguanine-DNA methyltransferase (MGMT) unmethylated glioblastoma with VAL-083 improves overall survival (OS), compared to historical control, in the adjuvant or recurrent setting.
Who can participate
Age range18 Years
SexALL
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General Inclusion Criteria:
* Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
* Patients must be ≥ 18 years old.
* Patients must have histologically confirmed initial diagnosis of primary intracranial WHO Grade IV malignant glioma (glioblastoma).
* Patients must have preliminary GBM MGMT status (tumor must be MGMT promoter unmethylated) determined prior to study entry. If initial MGMT status is determined to be "unmethylated", by an outside institution the patient may be enrolled and begin treatment. However, MGMT status must be retested following enrollment by central laboratory CLIA certified testing at MD Anderson.
* Patients must have Karnofsky Performance Status (KPS) \> 60% (i.e., 70, 80, 90 or 100).
* Adequate recovery from all recent surgery is required. At least 21-days must have elapsed from the time of any major surgery, including craniotomy/tumor resection. Patients must have recovered from all surgery-related toxicities to Grade 1 or less.
* Prior therapy with gamma knife or other focal high-dose radiation is allowed, but at least 2 weeks must have elapsed from the time of treatment, and the patient must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field.
* Patients having prior therapy with Laser Induced Thermal Therapy (LITT) i…
What they're measuring
1
Overall Survival
Timeframe: Every 30 days from randomization until patient death