Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03493932 : Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
PhasePhase 1
AgesMin: 22 Years Max: N/A
Eligibility
- INCLUSION CRITERIA:

To be eligible for entry into the study, a candidate must meet all the following criteria:

1. Be 22 years of age or older.

2. Have solitary 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.

6. Are not on steroids, or are on a stable (without an increase for the preceding 2 weeks)
or decreasing dose of steroids

7. Are willing to use an effective method of contraception during the clinical study as
defined on the consent and for 5 months (for women) or 7 months (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 or systemic cancer not related to a brain lesion.

2. Are pregnant or breastfeeding

3. Cannot have an MRI scan.

4. Are claustrophobic

5. Are not able to lie on their back for up to 60 minutes

6. Have an absolute lymphocyte count less than 500

7. Have multiple brain tumors, evidence of carcinomatous meningitis, gliomatosis cerebri,
or primary CNS lymphoma.

8. Have an unrelated autoimmune disease

9. Have a significant cardiac history, such as 2 or more MIs OR 2 or more coronary
revascularization procedures.

10. 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

11. Are currently undergoing treatment with another therapeutic agent for glioblastoma

12. Have a history of having been treated with immune therapy

13. Have an ejection fraction less than 50% on screening echocardiogram

14. Have positive serology for HIV, HBV and HCV

15. Have an active infection that requires systemic antibacterial, antiviral or antifungal
therapy

Less than 7 days prior to initiation of study drug therapy

16. Have a history of transfer of autologous or allogeneic T cells

17. Have cardiac Troponin T or I greater than 2 times the institutional upper limit of
normal at screening

18. 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.

19. Cannot speak English or Spanish fluently
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03493932      |      Link to official Clinicaltrials.gov listing
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