← Back to Search

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

Must not have

Patients with a clinically significant EKG on screening triggering an echocardiogram which is also clinically significant

Active viral infection requiring systemic treatment at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of enrollment of phase i portion of study (estimated to be 1 year)

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My heart screening tests showed significant findings.

Select...

I am currently on medication for a viral infection.

Select...

I am currently receiving treatment for an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of enrollment of phase i portion of study (estimated to be 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of enrollment of phase i portion of study (estimated to be 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of enrollment of phase i portion of study (estimated to be 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Secondary study objectives

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

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

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

~5520

Placebo

1995

Completed Phase 3

~2670