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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 belowSelect...
I have a high-grade brain tumor that needs radiation and TMZ treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreSecondary 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
37 Previous Clinical Trials
6,711 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,737 Total Patients Enrolled
NeoImmuneTechIndustry Sponsor
10 Previous Clinical Trials
437 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart screening tests showed significant findings.I have not received a live vaccine in the last 30 days.I have a high-grade brain tumor that needs radiation and TMZ treatment.I am currently on medication for a viral infection.My glioblastoma is IDH1 wildtype and MGMT promoter unmethylated.I've had surgery for my tumor, followed by radiation and TMZ treatment. I may have used Gliadel Wafers, glucocorticoids, or a TTF device.I am currently receiving treatment for an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: rhIL-7-hyFc
- Group 2: Randomized Phase II: Placebo
- Group 3: Phase II Expansion Arm: rhIL-7-hyFc
- Group 4: Randomized Phase II: rhIL-7-hyFc
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there capacity for additional participants in this experiment?
"This healthcare research initiative is actively enrolling subjects, as indicated on clinicaltrials.gov where it was first posted in early April of 2019 and revised at the end of July 2022."
Answered by AI
What is the participant enrollment for this research project?
"Affirmative. Clinicaltrials.gov data affirms that this trial, which was first listed on April 1st 2019, is currently searching for volunteers. Approximately 70 individuals need to be sourced from two separate medical facilities."
Answered by AI
Have there been any precedent research studies that have explored the use of rhIL-7-hyFc?
"rhIL-7-hyFc first arose as a research topic in 2002 with Memorial Sloan Kettering Cancer Center. Since then, 18762 studies have been completed and 207 active trials are underway, many of which take place at the Saint Louis medical centre."
Answered by AI
What types of ailments is rhIL-7-hyFc typically prescribed for?
"RhIL-7-hyFc is an effective therapeutic intervention for nitrosourea treatment, drafting advance directives, and managing untreatable advanced mycosis fungoides."
Answered by AI
Does this clinical experiment herald a new era of medical treatments?
"rhIL-7-hyFc has had a long and successful research history, having first been tested in 2002 as part of a clinical trial sponsored by Schering-Plough. This study was followed up by Phase 2 drug approval, leading to 207 ongoing studies across 935 cities and 36 countries today."
Answered by AI
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