Actively Recruiting
Phase II Trial of O6-benzylguanine and Temozolomide Therapy for Glioblastoma Multiforme With Infusion of Autologous P140K MGMT+ Hematopoietic Progenitors to Protect Bone Marrow
Led by Leland Metheny · Updated on 2025-11-21
16
Participants Needed
1
Research Sites
26 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
Researchers are evaluating a combination treatment involving P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine for adults with supratentorial glioblastoma or gliosarcoma who have recently undergone surgery to remove most or all of their brain tumor. This phase II trial aims to study how these chemotherapy drugs, which work by killing tumor cells or stopping their growth, interact with genetically modified stem cells designed to protect the bone marrow during treatment. Participants will first receive standard photon-based radiotherapy for six weeks, followed by stem cell mobilization. They will then undergo standard chemotherapy combined with the infusion of their own P140K MGMT-transduced hematopoietic progenitor cells to protect bone marrow function. The study evaluates this approach over multiple years, including an observation of tumor response and progression-free survival via imaging. During the study, participants will undergo regular assessments including MRI scans, laboratory tests for blood counts and organ function, and monitoring for adverse effects. Researchers will track overall survival, ability to complete treatment, and side effects related to bone marrow suppression. Follow-up extends up to 15 years after treatment to assess long-term outcomes and the persistence of the modified cells.
CONDITIONS
Brief Title
hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Histologically confirmed newly diagnosed supratentorial glioblastoma or gliosarcoma
- Underwent gross total or near total tumor resection (over 85% removed) within 35 days before enrollment
- Unmethylated MGMT status
- No IDH1 or IDH2 mutation confirmed by local testing
- ECOG performance status 0-1 or Karnofsky score ≥ 70
- No prior myelosuppressive chemotherapy or hematopoietic cell transplant before glioblastoma diagnosis
- Life expectancy of at least 12 weeks
- No plan for hypofractionated radiation therapy
- Adequate blood counts, liver, and kidney function within specified limits
- Post-operative steroids tapered to ≤ 8mg dexamethasone per day and stable or decreasing for 7 days before enrollment
- Women of childbearing potential must use single barrier contraception
- Able and willing to provide informed consent
- All surgical sutures removed prior to registration
- Clinically stable condition
- Candidate for autologous transplant based on transplant physician evaluation
- No active infection
- Availability of tumor tissue samples for molecular studies
- Negative screening for Hepatitis B, C, and HIV
You will not qualify if you...
- Known medical or hereditary conditions causing immunosuppression or other illnesses risking patient safety
- Known HIV positive status
- Pregnant or breastfeeding women
- Symptomatic lung disease or severe respiratory conditions including active infection, oxygen saturation < 90%, or DLCO < 50% predicted
- Heart failure or cardiac insufficiency with ejection fraction < 40%; recent acute coronary event within 6 months
- History of cardiac arrhythmias such as atrial fibrillation, tachyarrhythmia, or bradycardia
- Inability to undergo repeated MRI scans or allergy to gadolinium contrast
- Active illicit drug use or alcoholism
- Prior malignant disease except certain skin cancers or in situ carcinomas unless disease-free for at least 2 years
- Mental incapacity or psychiatric illness preventing informed consent
- History of Hepatitis B or C or severe hepatitis grade 3 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive standard of care photon-based radiotherapy over 6 weeks following surgery.
30 visits (in-person) for radiotherapy sessions
Duration - Duration as per protocol after radiotherapy
Participants undergo stem cell mobilization after completing radiotherapy to prepare for autologous hematopoietic progenitor infusion.
1 to 2 visits for stem cell collection
Duration - As outlined in the treatment protocol following stem cell mobilization
Participants receive chemotherapy with O6-benzylguanine and temozolomide along with infusion of their autologous P140K MGMT+ hematopoietic progenitors to protect bone marrow.
Multiple visits for chemotherapy administration and monitoring
Duration - Up to 15 years post-treatment
Participants are monitored for safety, tumor response, and overall survival after treatment completion.
Periodic visits for assessments and imaging
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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