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 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT03493932
Eligibility Criteria:
* INCLUSION CRITERIA:
To be eligible for entry into the study, a candidate must meet all the following criteria:
1. Be 18 years of age or older.
2. Have recurrent glioblastoma that is amenable to surgical resection.
3. Agree to undergo brain surgery.
4. Are eligible for 03-N-0164 "Evaluation and Treatment of Neurosurgical Disorders" protocol 5. Willing and able to appoint a durable power of attorney.
5. Willing and able to appoint a durable power of attorney
6. Are willing to use an effective method of contraception during the clinical study as defined on the consent and for 24 weeks (for women) or 33 weeks (for men) after the last dose of the study drug.
EXCLUSION CRITERIA:
Candidates will be excluded if they:
1. Have a bleeding disorder that cannot be corrected before invasive testing or surgery, or other medical conditions that would make surgery unsafe, such as lung or cardiac disease that would render them unable to tolerate the risk of general anesthesia, or severe immunodeficiency.
2. Has a known additional malignancy that is progressing or requires active treatment within 3 years of registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
3. Are pregnant or breastfeeding
4. Cannot have an MRI scan.
5. Are claustrophobic
6. Are not able to lie on their back for up to 60 minutes
7. Have primary CNS lymphoma.
8. Has received systemic immunosuppressive treatments, aside from systemic corticosteroids (such as methotrexate, chloroquine, azathioprine, etc) within six months of registration
9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
10. Have a significant cardiac history, such as 2 or more MIs OR 2 or more coronary revascularization procedures.
11. Have abnormal findings on ECG such as prolonged QT interval, T-wave abnormalities or arrhythmia. Abnormal findings on ECG will prompt an evaluation by a cardiologist prior to enrollment in the study
12. Are currently undergoing treatment with another therapeutic agent for glioblastoma
13. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
14. Have an ejection fraction less than 50% on screening echocardiogram
15. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) at the time of enrollment
16. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected) at the time of enrollment.
17. Have an active infection that requires systemic antibacterial, antiviral or antifungal therapy Less than 7 days prior to initiation of study drug therapy
18. Have a history of transfer of autologous or allogeneic T cells
19. Have a history of solid organ or tissue transplants
20. Have cardiac Troponin T or I greater than 2 times the institutional upper limit of normal at screening
21. At the time of enrollment, lack of consent capacity due to cognitive impairment that would make them incapable of understanding the explanation of the procedures in this study. Cognitive capacity to consent will be determined at the time of enrollment. Patients with mental disorders or those patients who are cognitively impaired yet still retain consent capacity will not be excluded.
22. Cannot speak English or Spanish fluently
23. Patients that require dexamethasone greater than 4 mg/ day or equivalent of steroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03493932
Study Brief:
Protocol Section:
NCT03493932