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:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT02302235
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-65
2. Ability and willingness to signed informed consent form
3. Astrocytoma grade 4 (glioblastoma multiforme, GBM, histologically confirmed, WHO criteria)
4. Documented surgical resection/debulking
5. Measurable contrast-enhancing GBM by MRI imaging ≤ two weeks before screening or prior to surgery if done ≤ 2 months before
6. Karnovsky Performance Score of 70 or more
Exclusion Criteria:
1. Acute intracranial or intratumoral hemorrhage \> Grade 1 either by MRI or CT scan ≤2 weeks of screening. (Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin may enter the study)
2. Prior treatment with any of the following: (a) small-molecule kinase inhibitor; (b) non-cytotoxic hormonal agent; (c) KD ≤6 months of enrollment
3. Planned continued use of glucocorticoids
4. Anticoagulation treatment with ≥ 1 mg/day coumadin ≤ 7 days prior to screening (low-dose \[≤ 1 mg/day\] coumadin, heparin, and low-molecular-weight heparin are permitted)
5. Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
6. History of non-glioma malignancy other than:
1. Surgically excised non-melanoma skin cancer or in situ carcinoma of the cervix
2. A malignancy diagnosed ≥2 years ago if the subject has had no evidence of disease for 2 years prior to screening
7. History of uncontrolled hyperlipidemia
8. Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements
9. History of human immunodeficiency virus, or hepatitis C
10. Failure to recover from \<CTCAE grade 2 toxicities related to prior therapy
11. Pregnancy or breastfeeding
12. Use of any investigational drug within 1 months of enrollment
13. Inability or unwillingness of subject to give written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02302235
Study Brief:
Protocol Section:
NCT02302235