Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas
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ClinicalTrials.gov Identifier: NCT02659800 |
Recruitment Status :
Terminated
(Sponsor decision)
First Posted : January 20, 2016
Last Update Posted : May 6, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphopenia Malignant Glioma | Other: Laboratory Biomarker Analysis Biological: NT-I7 Other: Placebo | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Dose Escalation - 3 levels - Group A Dexamethasone less/equal 0.75mg/day; Group B Dexamethasone greater/equal 4mg/day. At MTD Group A - w/outDexamethasone randomized Arm 1 placebo and Arm 2 MTD; Group B MTD w/ Dexamethasone single arm |
Masking: | Double (Participant, Care Provider) |
Masking Description: | Participant is blinded and partially randomized in the Pilot study. |
Primary Purpose: | Supportive Care |
Official Title: | 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 |
Actual Study Start Date : | October 30, 2018 |
Actual Primary Completion Date : | March 30, 2022 |
Actual Study Completion Date : | March 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A - Low Dexamethasone (LD)
Patients receive single dose of NT-I7 IM. Treatment continues in the absence of disease progression or unacceptable toxicity. Dose Escalation Laboratory Biomarker Analysis Correlative Studies |
Other: Laboratory Biomarker Analysis
Correlative studies Biological: NT-I7 Given IM |
Experimental: Arm B High Dexamethasone (HD)
Patients receive single dose of NT-I7 IM. Treatment continues in the absence of disease progression or unacceptable toxicity. Dose Escalation Laboratory Biomarker Analysis Correlative Studies |
Other: Laboratory Biomarker Analysis
Correlative studies Biological: NT-I7 Given IM |
Experimental: Arm A1 (LD) Control - Placebo
Patients receive single dose Placebo IM (blinded). Patients also on Dexamethasone </=0.75mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot Laboratory Biomarker Analysis Correlative Studies |
Other: Laboratory Biomarker Analysis
Correlative studies Biological: NT-I7 Given IM Other: Placebo Given IM |
Experimental: Arm A2 (LD) MTD
Patients receive single dose MTD NT-I7 IM determined in Arm A (Blinded) . Patients also on Dexamethasone <=0.75mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot Laboratory Biomarker Analysis Correlative Studies |
Other: Laboratory Biomarker Analysis
Correlative studies Biological: NT-I7 Given IM |
Experimental: Arm B1 HD MTD
Patients receive single dose MTD NT-I7 IM determined in Arm B (Blinded) . Patients also on Dexamethasone >= 4mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot Laboratory Biomarker Analysis Correlative Studies |
Other: Laboratory Biomarker Analysis
Correlative studies Biological: NT-I7 Given IM |
- Absolute total CD4 cell counts [ Time Frame: At 6 weeks (after standard radiation and temozolomide treatment completion) ]The primary treatment effect is defined as an absolute increase in CD4 counts in patients treated with glycosylated recombinant human interleukin-7 compared to the control group patients without glycosylated recombinant human interleukin-7 at week 6 after radiation treatment + temozolomide treatment.
- Optimal dose of glycosylated recombinant human interleukin-7 determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 [ Time Frame: 4 weeks ]The optimal dose will be selected based on the highest absolute increase of CD4 counts compared to the control if toxicity profiles are similar between the two dose levels. Otherwise, safety will be the first consideration for dose selection. The results of the two concurrent dexamethasone groups will be summarized with standard descriptive statistics. The dose selection criteria will be similar to the non-dexamethasone groups with priority on safety rather than the highest absolute increase of CD4 counts.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
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
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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
Exclusion Criteria
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659800
United States, Alabama | |
UAB Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3410 | |
United States, Maryland | |
Johns Hopkins Oncology Center | |
Baltimore, Maryland, United States, 21231 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Abrams Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 |
Study Chair: | Jian L Campian, MD, PhD | National Cancer Institute (NCI) |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT02659800 |
Other Study ID Numbers: |
ABTC 1403 UM1CA137443 ( U.S. NIH Grant/Contract ) IRB00073777 ( Other Identifier: JHMIRB ) |
First Posted: | January 20, 2016 Key Record Dates |
Last Update Posted: | May 6, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Glioma Lymphopenia Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Leukopenia Leukocyte Disorders Hematologic Diseases Immunologic Deficiency Syndromes Immune System Diseases |