Study of the Effect IL 7/ NT-I7 on CD4 Counts in Patients With High Grade Gliomas
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| ClinicalTrials.gov Identifier: NCT02659800 |
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Recruitment Status :
Recruiting
First Posted : January 20, 2016
Last Update Posted : December 19, 2018
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Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators:
National Cancer Institute (NCI)
Matthew Larson Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Brief Summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-17 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-17 on the CDR counts of patients in comparison to control participants. This study has both a Phase I and Pilot component.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphopenia Malignant Glioma | Other: Laboratory Biomarker Analysis Biological: NT-I7 Other: Placebo | Phase 1 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 75 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/Dexamethasone randomized Arm 1 placebo and Arm 2 MTD; Group B MTD w/out Dexamethasone single arm |
| Masking: | Double (Participant, Care Provider) |
| Masking Description: | participant is blinded and randomized in the second part of 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 |
| Estimated Primary Completion Date : | November 15, 2021 |
| Estimated Study Completion Date : | August 15, 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 |
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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 |
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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 |
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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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 4.0 [ 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 |
Criteria
Inclusion Criteria:
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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 >= 1,500/mcL
- Platelets >= 100,000/mcL
- 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
- 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 >= five years
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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
Information from the National Library of Medicine
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
Contacts
| Contact: Stuart A Grossman, MD | 410-955-8837 | jfisher@jhmi.edu | |
| Contact: Joy D Fisher, MA | 410-955-3657 | jfisher@jhmi.edu |
Locations
| United States, Alabama | |
| UAB Comprehensive Cancer Center | Not yet recruiting |
| Birmingham, Alabama, United States, 35294-3410 | |
| Contact: Thiru Pillay, RN 205-934-1842 thiru@uab.edu | |
| Principal Investigator: Burt Nabors, MD | |
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | Not yet recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Timothy Cloughesy, MD 310-825-5321 TCloughesy@mednet.ucla.edu | |
| Principal Investigator: Timothy Cloughesy, MD | |
| UCSF Comprehensive Cancer Center | Withdrawn |
| San Francisco, California, United States, 94115 | |
| United States, Maryland | |
| Johns Hopkins Oncology Center | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: Michaella Iacoboni, RN 410-955-4009 msheeh13@jhmi.edu | |
| Principal Investigator: Stuart A Grossman, MD | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Jennifer Barrs 617-632-6119 JenniferA_Barrs@DFCI.HARVARD.EDU | |
| Principal Investigator: Patrick Wen, MD | |
| United States, Michigan | |
| Josephine Ford Cancer Center at Henry Ford Hospital | Not yet recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Amy Williamson, RN awillia12@hfhs.org | |
| Contact: Emily Krozek, MHSA Ekrozek1@hfhs.org | |
| Principal Investigator: Tobias Walbert, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Jian L Campian, MD 314-747-4241 | |
| Principal Investigator: Jian Campian, MD | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Not yet recruiting |
| New York, New York, United States, 10021 | |
| Contact: Thomas Kaley, MD 212-639-5122 | |
| Principal Investigator: Thomas Kaley, MD | |
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | Not yet recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University CCC 336-713-6771 | |
| Principal Investigator: Glenn Lesser, MD | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | Not yet recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Cancer Center-Cares 216-444-7923 | |
| Principal Investigator: David Peereboom, MD | |
| Sub-Investigator: Manmeet Ahluwalia, MD | |
| United States, Pennsylvania | |
| Abrams Cancer Center of the University of Pennsylvania | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Clinical Trials Office-Abrams Cancer Center 800-474-9892 | |
| Principal Investigator: Arati Desai, MD | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Rita Johnson, RN johnsonr1@msx.upmc.edu | |
| Principal Investigator: Frank Lieberman, MD | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Matthew Larson Foundation
Investigators
| 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 History of Changes |
| Other Study ID Numbers: |
ABTC 1403 UM1CA137443 ( U.S. NIH Grant/Contract ) IRB00073777 ( Other Identifier: JHMIRB ) 118924 ( Other Grant/Funding Number: Matthew Larson Foundation ) |
| First Posted: | January 20, 2016 Key Record Dates |
| Last Update Posted: | December 19, 2018 |
| Last Verified: | December 2018 |
| 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 | |
Additional relevant MeSH terms:
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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 Dexamethasone acetate |
Dexamethasone BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors |