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|NCT02864368 : Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens|
|Ages||Min: 18 Years Max: N/A|
1. Age = 18 years.
2. Histopathologically proven newly-diagnosed primary glioblastoma with complete or
partial surgical resection. Biopsy not acceptable.
3. Patients must be 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-XRT adjuvant TMZ
initiation. If patients are decreasing steroid use, once they are at 2 mg/day, they
may be supplemented with hydrocortisone, at the discretion of the treating oncologist.
7. Hematology: ANC = 1500 cells/µL, Platelet count = 100,000 cells/µL, Hemoglobin = 9.0
8. Chemistry: ALT/AST = 2.5 times the upper limit of normal, Total bilirubin = 1.5 mg/dl.
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
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
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
9. Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a
history of anaphylactic reactions to shellfish proteins.
10. Patients with previous inguinal lymph node dissection, radiosurgery, brachytherapy, or
radiolabeled monoclonal antibodies.
11. Prior allogeneic solid organ transplant.
12. Currently receiving or ever received immunosuppressive therapy for an autoimmune
disorder or an organ transplant.
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