Actively Recruiting
hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
Led by Leland Metheny · Updated on 2025-11-21
16
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
L
Leland Metheny
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effect of P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine in treating participants with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor (resected). Chemotherapy drugs, such as 6-benzylguanine, temozolomide, and carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing. Placing P140K MGMT, a gene that has been created in the laboratory into bone marrow making the bone more resistant to chemotherapy, allowing intra-patient dose escalation which kills more tumor cells while allowing bone marrow to survive.
CONDITIONS
Official Title
hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Histologically confirmed newly diagnosed supratentorial glioblastoma or gliosarcoma
- Surgery removing over 85% of enhancing tumor with gross total or near total resection
- Unmethylated MGMT gene status
- Absence of IDH1 or IDH2 mutation on tumor tissue
- ECOG performance status 0-1 or Karnofsky score of 70 or higher
- No prior chemotherapy or hematopoietic cell transplantation before GBM diagnosis
- Life expectancy of at least 12 weeks
- No plan for hypofractionated radiation therapy
- Adequate blood counts, liver and kidney function within 2 weeks before treatment
- Steroid dose tapered to 8 mg dexamethasone or less per day and stable or decreasing for 7 days
- Agreement to use single barrier contraception if of child-bearing potential
- Able and willing to provide informed consent
- All surgical sutures removed before registration
- Clinically stable condition
- Candidate for autologous transplant as evaluated by transplant physician
- Negative screening for Hepatitis B, C, and HIV
- No active infection
- Availability of tumor tissue slides or samples for molecular studies
You will not qualify if you...
- Any medical or hereditary condition causing immunosuppression or other illness jeopardizing safety
- Known HIV positive status
- Pregnant or breastfeeding women
- Severe lung disease or active pulmonary infection, including low oxygen levels or low lung diffusion capacity
- Heart failure with ejection fraction below 40% or recent heart attack within 6 months
- Known cardiac arrhythmias
- Inability to undergo repeated MRI scans or allergy to MRI contrast
- Active illicit drug use or alcoholism
- Prior malignant disease except certain skin or in situ cancers unless disease-free for 2 years
- Mental incapacity or psychiatric illness preventing informed consent
- History of severe Hepatitis B or C infection or grade 3 or higher hepatitis due to risk of liver toxicity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
M
Melissa Bratley, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here