Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients With Glioblastoma

Inclusion Criteria

• Be willing and able to provide written informed consent for the trial
• PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: Have histologically confirmed World Health Organization grade IV malignant glioma (glioblastoma or gliosarcoma); participants will also be eligible if the original histology was lower grade glioma and there is suspected transformation to glioblastoma based on imaging findings; if the final pathology report after resection fails to confirm recurrent glioblastoma or gliosarcoma, the subject will be followed for adverse events (AEs) and survival, but excluded for other primary and secondary objective analysis; the subject will be replaced
• PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: Have histologically confirmed World Health Organization grade IV glioma (glioblastoma or gliosarcoma)
• PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: Be at first relapse; Note: relapse is defined as progression following initial therapy (i.e., radiation, chemotherapy, or radiation plus (+) chemotherapy); if the participant had a surgical resection for relapsed disease and no antitumor therapy instituted for up to 12 weeks, this is considered one relapse; for participants who had prior therapy for a lower grade glioma, the surgical diagnosis of glioblastoma or gliosarcoma will be considered first relapse
• PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: Patients must have completed standard radiation therapy with concurrent temozolomide (TMZ) within 5 weeks (wks) of enrollment and must not have evidence of progressive disease on post treatment imaging; progression can only be defined using diagnostic imaging if there is new enhancement outside of the radiation field (beyond the high-dose region or 80% isodose line) or if there is unequivocal evidence of viable tumor on histopathologic sampling (e.g., solid tumor areas [i.e,> 70% tumor cell nuclei in areas], high or progressive increase in mindbomb homolog 1[MIB-1] proliferation index compared with prior biopsy, or evidence for histologic progression or increased anaplasia in tumor); Note: given the difficulty of differentiating true progression from pseudoprogression, clinical decline alone, in the absence of radiographic or histologic confirmation of progression, will not be sufficient for definition of progressive disease in the first 12 weeks after completion of concurrent chemoradiotherapy
• PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: Have measurable disease consisting of a minimal volume of 1 cm^3
• CMV seropositive
• PHASE I AND PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: Be willing to provide tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
• PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: Be willing to provide tissue from an archival tissue sample
• Have a performance status of >= 60 on the Karnofsky performance status (KPS)
• If patient is on steroids, patient must be on a stable or decreasing dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day at the time of screening and consent; if on steroids at the time of screening, the dose will need to be tapered and discontinued at least 5 days prior to CMV T cell infusion
• Absolute neutrophil count (ANC) >= 1, 500 /mcL (performed within 14 days [+3 working days] of treatment initiation)
• Platelets >= 100, 000 / mcL (performed within 14 days [+3 working days] of treatment initiation)
• Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (performed within 14 days [+3 working days] of treatment initiation)
• Serum creatinine OR measured or calculated (creatinine clearance should be calculated per institutional standard) creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) = = 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (performed within 14 days [+3 working days] of