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hSTAR GBM: A Study for Glioblastoma and Gliosarcoma

This study, called hSTAR GBM, is testing a new approach for adults aged 18-75 with newly diagnosed glioblastoma or gliosarcoma, a type of brain tumor, who have recently had surgery to remove most of their tumor. It combines standard radiation therapy (Photon Based Radiotherapy) and chemotherapy drugs like temozolomide and O6-benzylguanine with a special treatment called P140K-MGMT. This P140K-MGMT treatment involves modifying your own bone marrow cells to make them more resistant to chemotherapy, potentially allowing for higher, more effective doses of chemotherapy. The study aims to see how many participants can complete treatment, the side effects experienced, and how long participants live. The current status of this study is unclear, and it plans to enroll 16 participants.

Study design
This is an interventional study with a planned enrollment of 16 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years to assess treatment completion and up to 15 years to measure overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05052957

hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Leland Metheny
~16 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:P140K-MGMTO6-benzylguaninePhoton Based RadiotherapytemozolomideFilgrastimcarmustine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of participants able to complete treatment
Measured over 10 years after start of study
+2 more outcomes measured

Conditions

Glioblastoma Multiforme
Glioblastoma Multiforme, Adult
Supratentorial Glioblastoma
Supratentorial Gliosarcoma

Explore related trials

GlioblastomaGliosarcomaMGMT Gene

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Leland Metheny, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Who to contact

Melissa Bratley, RN
[email protected]
1-800-641-2422
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone gross total tumor resection or near gross total resection (resection of \>85% of enhancing tumor demonstrated by MRI) are eligible up to 35 days post-operatively. Patients with primarily infratentorial disease, or with multifocal,or leptomeningeal dissemination of disease will be excluded. In general, patients will not have \> 1 cm residual measurable or evaluable disease after surgical tumor resection.
Patient must have unmethylated MGMT
Absence Of IDH1 or IDH2mutation on tumor tissue by a CLIA-approved immunohistochemistry or DNA sequencing test on local testing
Patients aged 18-75 years.
ECOG performance status 0-1or Karnofsky ≥ 70.
No myelosuppressive chemotherapy or hematopoietic cell transplantation prior to the diagnosis of GBM and no prior chemotherapy (including Gliadel BCNU wafers) for GBM
Life expectancy of at least 12 weeks.
No plan for hypofractionated radiation therapy
Adequate hematologic (absolute neutrophil count (ANC)≥ 1000/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.5, hepatic (Bilirubin ≤ 2.0 mg/dl, AST and ALT less than or equal to 3 times institutional upper limit of normal, prothrombin time \<1.2 times normal), and renal (serum creatinine ≤ 2.0 mg/dl or Creatinine Clearance ≥ 60mL/min/1.73 m2for subjects with serum creatinine levels above institutional normal). These tests will be repeated within 2 weeks of treatment with BG and TMZ, and must meet the same criteria. -Post-operative steroids are i) tapered to ≤ 8mg dexamethasone/day(or equivalent)and ii) patient has been on a stable or decreasing steroid dose for the 7 days prior to enrollment
Patients of child-bearing potential must agree to using single barrier contraception.
Must be willing and able to understand provide informed consent.
Patient must have all sutures removed prior to registration
Patient must be considered to be clinically stable.
The subject will be identified as a candidate for an autologous transplant via an evaluation by a transplant physician per standard of care. Participants will be screened by their transplant physician and social work for a history of substance abuse per screening tool such as SIPAT. Any participant with positive screen for significant substance abuse will undergo evaluation and must have a treatment, management plan in place and must have formal review of medical team prior to initiation of transplant procedures.
No evidence of active infection.
Availability of 10unstained slides or FFPE sample of tumor for molecular or histopathological studies.
Negative screening for Hepatitis B, C and HIV

Exclusion

Any known medical or hereditary condition associated with immunosuppression;orothermedical illness which may jeopardize patient safety.
Known history of HIV seropositivity. This exclusion is included for two reasons. First, there is evidence of decreased marrow reserve in HIV+ patients and antiviral treatment is associated with myelosuppression. Thus, drug treatment designed to be myelosuppressive may bemore toxic in this patient population. Second, extensive laboratory culturing of the bone marrow and peripheral blood progenitor cells is required. No preclinical samples which are HIV+ have been evaluated with the gene transfer modality proposed and thus the feasibility and safety of gene transfer and selection in HIV+ samples cannot yet be advocated. Such studies are planned so as to not preclude HIV+ patients in later studies.
Pregnant or lactating women. There is data to indicate that BCNU and TMZ is teratogenic and carcinogenic. Thus, its use in pregnant women would confer unnecessary risk to the fetus.
Patients with symptomatic pulmonary disease and other severe co-morbid respiratory conditions, including patients with active pulmonary infection and/or pulse oximetry \< 90% and a corrected DLCO \< 50% of predicted. However, subjects with a corrected DLCO in the range of 50-70% should have Pulmonologyclearance prior to intervention.
Patients with known diagnosis heart failure or cardiac insufficiency and an LVEF of \< 40%. History of acute coronary event including MI within 6 months prior to study enrollment.
Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmiaor bradycardia.Inability to undergo repeated MRI evaluation; or allergy or intolerance of Gadolinium-containing contrast agent.
Active illicit drug use or diagnosis of alcoholism.
Prior diagnosis of any malignant disease with the exception of non-melanomatous skin cancer, or carcinoma in situof the cervix, bladder, prostate, or breast, unless patient has been disease-free/in remission for ≥2 years prior to date of study enrollment.
Mental incapacity or psychiatric illness preventing informed consent.
History of Hepatitis B or C or Hepatitis grade ≥3 are excluded due to the potential for additional hepatotixicity

What this trial measures

  • Percent of participants able to complete treatment10 years after start of study

    To evaluate and compare the feasibility of introducing and expressing P140K MGMT cDNA using a lentiviral-based provirus in autologous hematopoietic stem cells harvested from newly diagnosed IDH-1 WT GBM with unmethylated MGMT promoter using two different sequences of stem cell mobilization. 1\. What percent of patients who enter trial can complete treatment.

  • Incidence of adverse eventsUp to 30 days post-treatment

    proportion of participants experiencing a grade 3 or higher AE/SAE

  • Overall SurvivalUp to 15 years post-treatment

    Median overall survival in months.