Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Lymphopenia, Malignant Glioma

In brief

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.

Key facts

Study ID: NCT02659800
Run by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
People needed: 12
Starts: 2018-10-30
Expected to finish: 2023-10-03
Last updated by the study team: 2023-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed high grade glioma by pathology (World Health Organization [WHO] grade III and IV)
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 (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is allowed
Patients must have CD4 =< 300 cells/mm\^3 in the last week (7 days) of standard radiation + temozolomide treatment (58-60 Gy radiation with temozolomide 75 mg/m2 daily during radiation)
Absolute neutrophil count >= 1,000/mcL
Platelets >= 50,000/mcL (need to confirm before administering study drug)
Hemoglobin >= 9 g/dL
Total bilirubin =< institutional upper limit of normal
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73 m\^2 for patients with creatinine levels above institutional normal
Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal
Patients must have a Karnofsky performance status (KPS) >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
Patients must be able to provide written informed consent
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 (either two barrier methods or a barrier method plus a hormonal method) or abstinence prior to study entry and for the duration of study participation (through at least 90 days after the last study injection); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Dexamethasone dose must be provided for treatment group assignment:
Group A: patients not on dexamethasone or on a dose =< 0.75 mg daily (or equivalent of an alternative corticosteroid)
Group B: patients who require dexamethasone >= 4 mg daily (or equivalent of an alternative corticosteroid) ** 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

You may not qualify if…

Patients receiving any other investigational agents are ineligible
Patients with known hypersensitivity to NT-I7 or any component used in the vehicle/formulation are ineligible
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with NT-I7
Patients with human immunodeficiency virus (HIV) are excluded
Patients with a known or screening-period-determined corrected QT (QTc) interval > 450 msec and patients who require a therapy with a drug known to prolong the QT/QTc interval, are ineligible
Patients with a history of or who currently have evidence of autoimmune disease (other than autoimmune thyroid disease managed with thyroid hormone replacement or vitiligo) including: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc., are ineligible

Where it is running

UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
Johns Hopkins Oncology Center — Baltimore, Maryland, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital — Detroit, Michigan, United States
Washington University — St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
Abrams Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.