Study on rhIL-7-hyFc for Increasing Lymphocyte Counts in Patients with Newly Diagnosed Non-severe Lymphopenic Gliomas After Radiation and Temozolomide
Sponsor: Washington University School of Medicine
ClinicalTrials ID:NCT03687957
This clinical trial is testing a new treatment, rhIL-7-hyFc, to see if it can safely increase lymphocyte counts in patients with high-grade glioma, a type of brain cancer, who have received standard radiation and temozolomide treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if rhIL-7-hyFc can safely boost lymphocyte (a type of white blood cell) counts in patients with high-grade glioma (HGG). In the first phase, the safety of rhIL-7-hyFc will be tested in patients with HGG. The second phase will explore its effect on lymphocyte counts in patients receiving standard radiation therapy and temozolomide, using a placebo-controlled approach.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with certain types of gliomas (brain tumors) that need radiation and temozolomide treatment.
- For Phase 2 only: Must have a specific genetic type of glioblastoma multiforme.
- Must have had surgery followed by radiation and temozolomide treatment. Previous use of Gliadel Wafers, glucocorticoid therapy, and tumor treating fields (TTF) devices is allowed.
- Must have adequate organ and bone marrow function, as shown by specific blood test results:
- Neutrophil count of at least 1,000/mcL
- Platelet count of at least 75,000/mcL
- Hemoglobin level of at least 8 g/dL
- Total bilirubin no more than 3 times the normal limit
- AST/ALT no more than 3 times the normal limit
- Lymphocyte count of at least 600/mcL (for Phase I and randomized Phase II only)
- Must be able to care for themselves with occasional help, as measured by a Karnofsky Performance Status of 60% or higher.
- Must be able to provide written informed consent.
- Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use contraception during treatment.
- Must be at least 18 years old.
Exclusion Criteria
- Currently taking other experimental drugs that may affect lymphocyte counts.
- Pregnant women cannot participate due to unknown risks to the baby. Breastfeeding should be stopped if the mother is treated with rhIL-7-hyFc.
- Have an active viral infection needing treatment at the time of screening.
- Have an active autoimmune disease requiring treatment, such as rheumatoid arthritis, psoriasis, multiple sclerosis, lupus, or Crohn's disease. Certain stable conditions like vitiligo or type I diabetes are allowed.
- Have received a live vaccine within 30 days before starting the study. Most flu shots are allowed, but nasal spray vaccines are not.
- Have significant heart enzyme levels or heart issues on screening tests.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Washington University School of Medicine | 63110 | Saint Louis | Missouri |
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