Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT01249105
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed glioblastoma or gliosarcoma. Participants will be eligible if the orginal histology was low-grade glioma and a subsequent histological diagnosis of glioblastoma or gliosarcoma is made.
* Unequivocal evidence for tumor progression by MRI or CT scan. A scan should be performed within 14 days of registration. The same type of scan must be used throughout the period of protocol treatment for tumor measurement. MRI scans are preferred whenever possible. If participants in Part 2 of the study are taking corticosteroids, the dose must be stable or decreasing for at least 5 days prior to the scan.
* Must have recovered from the toxic effects of prior therapy. From the start of scheduled study treatment, the following time periods must have elapsed: 4 weeks from any investigational agent, 4 weeks from cytotoxic therapy, or 4 weeks from other anti-tumor therapies.
* Must have failed prior radiation therapy and must have an interval of at least 12 weeks from the completion of radiation therapy.
* Prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of progressive disease based upon nuclear imaging, MR spectroscopy, or histopathology.
* Participants having undergone recent resection of recurrent or progressive tumor will be eligible as long as the following conditions apply: a) they have recovered from the effects of surgery, b) residual disease following resection of recurrent tumor is not mandated for eligibility. To best assess the extent of residual disease post-operatively, and MRI or CT scan should be done no later than 96 hours following surgery or at least 4 weeks post-operatively, in either case within 14 days prior to registration. If participants in Part 2 of the study are taking corticosteroids, the dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening MRI or CT scan and the start of treatment, a new baseline MRI or CT is required.
* 18 years of age or older
* Life expectancy of \> 8 weeks
* Karnofsky performance status 60 or greater
* Normal organ and marrow function as outlined in the protocol
* At least 35-45 paraffin slides (standard thickness of 4 microns) from any prior surgery available for correlative studies
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Participants must be registered for the Ivy Consortium Tissue and Data Study.
Additional Part 1 Eligibility Criteria:
* Must be deemed by the site Investigator to be an appropriate candidate for surgical resection.
* Must have frozen tumor sample (minimum of 100mg of tissue) from any prior surgery available for correlative studies
* Unequivocal evidence for tumor progression by MRI or CT scan. For this scan only, increasing corticosteroid doses are acceptable.
Additional Part 2 Eligibility Criteria:
* Subjects with anaplastic gliomas who meet other eligibility criteria are eligible.
Exclusion Criteria:
* Participants who have received therapy for more than two prior relapses
* Prior treatment with Akt inhibitors, PI3K inhibitors, mTOR inhibitors, or anti-angiogenic agents
* Must not be on an enzyme-inducing anti-epileptic drug. If previously on an EIAED, the patient must be off of it for at least two weeks prior to registration.
* Receiving any medications or substances that are strong inhibitors or inducers of CYP3A4
* Receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206
* History or current evidence of heart disease
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease, chronic renal disease, chronic pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements.
* Poorly controlled diabetes mellitus
* Pregnant or breastfeeding women
* Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell squamous cell carcinoma of the skin
* HIV-positive individuals
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01249105
Study Brief:
Protocol Section:
NCT01249105