A Phase I and Pilot Study of the Effect of rhIL-7-hyFc (NT-I7) on CD4 Counts in Patients with High Grade Gliomas and Severe Treatment-Related CD4 Lymphopenia after Concurrent Radiation and Temozolomide
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test whether treatment with the experimental agent, CYT107 will increase low CD4 counts caused by radiation and chemotherapy.
18 years or older. Patients must have histologically confirmed high grade glioma by pathology (World Health Organization [WHO] grade III and IV)o Patients' post-operative treatment must have included at least 80% of standard radiation and concomitant temozolomide; patients may not have received any other prior chemotherapy, immunotherapy or therapy with biologic agent, or hormonal therapy for their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is allowed.o Patients must have CD4 equal to less than 200 cells/mm^3 in the last week (7 days) of standard radiation + temozolomide treatmentoAbsolute neutrophil count greater than equal to 1,500/mcLoPlatelets greater than equal to 100,000/mcLoHemoglobin greater than equal to 9 g/dLoTotal bilirubin equal to less than institutional upper limit of normaloAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) equal to less than 2.5 x institutional upper limit of normaloCreatinine equal to less than institutional upper limit of normal OR creatinine clearance greater than equal to 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normaloActivated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) equal to less than 1.5 x institutional upper limit of normalo Patients must be able to care for himself/herself with occasional help from others)o Patients must be able to provide written informed consento Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of childbearing potential and men must agree to use two birth control methods or abstinence prior to study entry and for the duration of study participation.o Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for greater than equal to five years
Study participants will be divided into two groups depending on their use of the corticosteroid, dexamethasone: •Participants not on dexamethasone or at a dose equal to or lower than 0.75 mg a day will be enrolled in Group A•Participants who require dexamethasone at a dose greater than 0.75 mg a day will be enrolled in Group BAll participants will come weekly to the clinic during the first six weeks of the study, and then about every 4 weeks. You will have blood samples drawn weekly throughout the study.
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