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rhIL-7-hyFc for Brain Tumor

Phase 1 & 2
Recruiting
Led By Milan Chheda, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with World Health Organization (WHO) grade III, grade IV, and high risk grade II gliomas that require RT and TMZ treatment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test whether rhIL-7-hyFc can safely be administered to patients with HGG and whether it has an effect on lymphocyte counts.

Who is the study for?
This trial is for adults with certain high-grade brain tumors (gliomas) that need radiation and Temozolomide treatment. Participants must have adequate organ function, not be pregnant, agree to use contraception, and can't have active infections or autoimmune diseases requiring systemic treatment.Check my eligibility
What is being tested?
The study evaluates rhIL-7-hyFc's safety and its effect on lymphocyte counts in patients with high-grade gliomas undergoing standard treatments. It includes a phase I dose-escalation part followed by a phase II placebo-controlled comparison alongside radiation therapy and Temozolomide.See study design
What are the potential side effects?
Potential side effects of rhIL-7-hyFc are not detailed here but may include reactions related to immune system stimulation since it aims to increase lymphocyte counts. Standard cancer treatment side effects like fatigue, nausea, or hair loss might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a high-grade brain tumor that needs radiation and TMZ treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Safety and tolerability of rhIL-7-hyFc as measured by dose-limiting toxicities (DLTs)
Phase I: Safety and tolerability of rhIL-7-hyFc as measured by the maximum tolerated dose (MTD) - Phase I only
Phase II Expansion Cohort: Progression-free survival (PFS)
+1 more
Secondary outcome measures
Phase I and Randomized Phase II: Immunogenicity as measured by anti-drug antibodies
Phase I and Randomized Phase II: Immunogenicity as measured by neutralizing anti-drug antibodies
Phase I: Absolute lymphocyte count (ALC)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Randomized Phase II: rhIL-7-hyFcExperimental Treatment4 Interventions
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
Group II: Randomized Phase II: PlaceboExperimental Treatment4 Interventions
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
Group III: Phase II Expansion Arm: rhIL-7-hyFcExperimental Treatment3 Interventions
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
Group IV: Phase I: rhIL-7-hyFcExperimental Treatment4 Interventions
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood sample
2009
Completed Phase 3
~5460
Placebo
1995
Completed Phase 3
~2670
Temozolomide
2010
Completed Phase 3
~1930
Radiation therapy
2013
Completed Phase 3
~2850

Find a Location

Who is running the clinical trial?

The Foundation for Barnes-Jewish HospitalOTHER
39 Previous Clinical Trials
6,746 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,746 Total Patients Enrolled
NeoImmuneTechIndustry Sponsor
10 Previous Clinical Trials
437 Total Patients Enrolled

Media Library

rhIL-7-hyFc Clinical Trial Eligibility Overview. Trial Name: NCT03687957 — Phase 1 & 2
Brain Tumor Research Study Groups: Phase I: rhIL-7-hyFc, Randomized Phase II: Placebo, Phase II Expansion Arm: rhIL-7-hyFc, Randomized Phase II: rhIL-7-hyFc
Brain Tumor Clinical Trial 2023: rhIL-7-hyFc Highlights & Side Effects. Trial Name: NCT03687957 — Phase 1 & 2
rhIL-7-hyFc 2023 Treatment Timeline for Medical Study. Trial Name: NCT03687957 — Phase 1 & 2
~41 spots leftby Jan 2032
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