The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-I7 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-I7 on the CD4 counts of patients in comparison to control participants. This study has both a Phase I and Pilot component.
Phase I: To determine the MTD (Maximum Tolerated Dose) and select optimal biological doses (OBD) of NT-I7 in HGG patients with severe lymphopenia
Pilot Study: To test the effect of NT-I7 on CD4 counts compared to control
OUTLINE: Patients are assigned to 1 of 2 groups depending on their use of dexamethasone.
GROUP A: Patients not on dexamethasone (or equivalent of an alternative corticosteroid), or on a dose lower than a physiologic dose (=< 0.75 mg daily)
GROUP B: patients who require dexamethasone (or equivalent of an alternative corticosteroid) => 4 mg daily
Patients must have been on the group assignment dose of corticosteroids for at least 5 days prior to the dose of NT-I7. Corticosteroid dose changes prior to the start of treatment are allowed as long as they do not alter patient's group assignment.
PHASE I TREATMENT PLAN
All patients (both Groups A and B) will be given a single dose of NT-I7 by intramuscular injection starting at 60 g/kg, within one week after completing concurrent RT+TMZ and before starting adjuvant TMZ treatment, during the standard post-radiation break. Following this period, as per standard treatment, patients will go on to receive adjuvant temozolomide on Days 1-5 of 28-day cycles for 6 cycles. There should be about six weeks between the study injection and the start of adjuvant temozolomide; thus the start of adjuvant TMZ will be approximately two weeks later than the usual start, which is 4 weeks post-end of radiation. Patients who are delayed from receiving or are not able to receive adjuvant TMZ treatment may continue on study; adjuvant TMZ treatment is not a requirement for participation.
PILOT STUDY TREATMENT PLAN
GROUP A: participants will be given either a placebo (NT-I7 diluent) or one dose of NT-I7 at the Phase I Group A OBD by intramuscular injection within one week after completing concurrent RT+TMZ and before starting adjuvant TMZ treatment, during the standard post-radiation break.
GROUP B: participants will be given one dose of NT-I7 at the Phase I Group B OBD by intramuscular injection within one week after completing concurrent RT+TMZ and before starting adjuvant TMZ treatment, during the standard post-radiation break.
After completion of study treatment, patients are followed up every 2 months for 2 years and then every 6 months thereafter.
|Treatment||laboratory biomarker analysis, Placebo, Glycosylated Recombinant Human Interleukin-7, NT-I7|
|Clinical Study Identifier||NCT02659800|
|Sponsor||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Last Modified on||3 September 2020|
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