The investigators have developed a phase I/II clinical trial to evaluate the effect of rhIL-7-hyFc on lymphocyte counts in patients with high grade glioma (HGG). A phase I study will test whether rhIL-7-hyFc can be safely administered to patients with HGG. Six doses of rhIL-7-hyFc will be tested using a mix of Accelerated Phase and standard 3+3 dose-escalation design. The phase II portion to test effect of rhIL-7-hyFc on lymphocyte counts will use placebo-controlled randomization in HGG patients whose treatment include the standard radiation therapy (RT) and temozolomide (TMZ).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
-Given by intramuscular injection
-Given by intramuscular injection
-Standard of care
-Standard of care
Washington University School of Medicine
St Louis, Missouri, United States
Phase I Only: Safety and Tolerability of rhIL-7-hyFc as Measured by the Maximum Tolerated Dose (MTD) of rhIL-7-hyFc
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the non-tolerated dose. A total of at least 6 patients must be treated at a dose level for it to be considered the MTD.
Time frame: Within 30 days of treatment start
Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs)
-DLTs are defined in the protocol.
Time frame: Within 30 days of treatment start
Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC)
Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.
Time frame: Baseline to Prior to adjuvant TMZ (approximately week 4)
Phase II Expansion Arm: Progression-free Survival (PFS)
-Defined from date of surgery to date of progression or death due to disease or date of last clinical follow up.
Time frame: Through completion of follow-up (estimated to be 5 years and 6 months)
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs)
* The formation of anti-drug antibodies (ADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure. The data will be presented if anti-drug antibodies are detected or not detected in the samples. * Week 1 will be prior to injection of 1st dose of rhIL-7-hyFc, week 13 will be prior to the 2nd dose of rhIL-7-hyFc, and week 45 will be 8 weeks after the last dose of rhIL-7-hyFc.
Time frame: Week 1, Week 13, Week 25, and Week 45
Phase I: Percent Change in Absolute Lymphocyte Count (ALC)
Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.
Time frame: Baseline to Prior to adjuvant TMZ (approximately week 4)
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