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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT02864368
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. Histopathologically proven newly-diagnosed primary glioblastoma with complete or partial surgical resection. Biopsy not acceptable.
3. Patients must be cytomegalovirus (CMV) seropositive.
4. The tumor must be supratentorial.
5. Karnofsky performance status of ≥ 70.
6. Stable or decreasing steroid dose (≤ 4 mg/day) at time of post-radiation treatment (XRT) adjuvant TMZ initiation. If patients are decreasing steroid use, once they are at 2 mg/day, they may be supplemented with physiologic replacement hydrocortisone therapy (20-30 mg/day in divided doses), at the discretion of the treating oncologist.
7. Hematology: absolute neutrophil count (ANC) ≥ 1500 cells/µL, Platelet count ≥ 100,000 cells/µL, Hemoglobin ≥ 9.0 g/dl
8. Chemistry: ALT/AST ≤ 3.0 times the upper limit of normal (ULN), Total bilirubin ≤ 1.5 mg x ULN (Exception: Patient has known Gilbert's Syndrome or patient has suspected Gilbert's Syndrome, for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)
Exclusion Criteria:
1. Radiographic or cytologic evidence of leptomeningeal or multifocal disease at any time prior to study entry.
2. Prior conventional antitumor therapy, other than steroids, RT or TMZ therapy given for glioblastoma.
3. Pregnant or need to breast feed during the study period.
4. Not adhering to pregnancy prevention recommendations.
5. Active infection requiring intravenous antibiotics or an unexplained febrile (\> 101.5 F) illness.
6. Immunosuppressive disease or human immunodeficiency virus infection.
7. Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease.
8. Allergic or unable to tolerate TMZ for any reason. Any patient that successfully completed at least 5 weeks of Temodar during standard of care XRT/TMZ and whose blood counts meet the eligibility requirements (inclusion #7) within 4 weeks post XRT/TMZ is eligible.
9. Patients with previous inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies.
10. Prior allogeneic solid organ transplant.
11. Currently receiving or ever received immunosuppressive therapy for an autoimmune disorder or an organ transplant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02864368
Study Brief:
Protocol Section:
NCT02864368