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Glioblastoma MultiformePhase 2hSTAR GBMNCT05052957

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

A Phase 2 study testing P140K-MGMT, O6-benzylguanine and Photon Based Radiotherapy in people with Glioblastoma Multiforme and Glioblastoma Multiforme, Adult, run by Leland Metheny at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
P140K-MGMT, O6-benzylguanine and Photon Based Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
20 Jan 2023to 1 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone tumor resection are eligible up to 35 days postoperatively. Participants with primarily infratentorial disease, or with multifocal, or leptomeningeal dissemination of disease will be excluded. In general, participants will not have > 1 cm residual measurable or evaluable disease after surgical tumor resection.
  • Participant must have unmethylated MGMT
  • Absence of IDH1 or IDH2 mutation on tumor tissue by a CLIA-approved immunohistochemistry or DNA sequencing test on local testing.
  • Participants aged 18 years or older.
  • ECOG performance status 0-1or Karnofsky ≥ 70.
  • Life expectancy of at least 12 weeks.
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  • No plan for hypofractionated radiation therapy
  • Adequate hematologic and hepatic function:
  • CBC/differential obtained within 28 days prior to registration:
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Note: the use of G-CSF or other intervention to achieve Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 is acceptable)
  • Platelets ≥ 50,000 cells/mm3 (Note: the use of transfusion or other intervention to achieve Platelets ≥ 50,000 cells/mm3 is acceptable)
  • Hemoglobin ≥ 9.0 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥9.0 g/dl is acceptable)
  • Adequate hepatic function within 28 days prior to registration:
  • Bilirubin ≤ 3 ULN
  • ALT and AST ≤ 3 x ULN
  • Participants of child-bearing potential must agree to use single barrier contraception from time of trial entry to completion of the last cycle of chemotherapy.
  • Must be willing and able to understand and provide informed consent.
  • Participant must be considered to be clinically stable.
  • The participant will be identified as a candidate for an autologous transplant via an evaluation by a transplant physician per standard of care.
  • No evidence of active infection.
  • Participant must have the ability to understand and willingness to sign an informed consent document.

Who cannot join

  • Any known medical or hereditary condition associated with immunosuppression; or other medical illness, which may jeopardize participant safety.
  • 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.
  • Participants with a corrected DLCO or FEV1 < 50% of predicted.
  • Participants with known diagnosis heart failure or cardiac insufficiency and an LVEF of < 40%.
  • Inability to undergo repeated MRI evaluation; or allergy or intolerance of Gadoliniumcontaining contrast agent.
  • Active illicit drug use or diagnosis of active alcoholism.
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  • Prior diagnosis of any malignant disease with the exception of non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder, prostate, or breast, unless the participant has been disease-free/in remission for ≥2 years prior to date of study enrollment.
  • Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness.
  • Serologic status reflecting active hepatitis B or C infection. Individuals that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive individuals will be excluded).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Melissa Bratley, RN contact

1-800-641-2422

CTUreferral@uhhospitals.org

United States1 site, 1 recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Leland Metheny, MD, 216-844-0130, Leland.metheny@uhhospitals.org

    Recruiting

Other trials in United States

About this study

Official title: Phase II Trial O6-benzylguanine(BG) and Temozolomide(TMZ) Therapy of Glioblastoma Multiforme (GBM) With Infusion of Autologous P140K MGMT+Hematopoietic Progenitors to Protect Hematopoiesis

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.

Being tested
P140K-MGMT, O6-benzylguanine, Photon Based Radiotherapy, temozolomide, Filgrastim
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P140K-MGMTBiological

    Ex Vivo Cultured P140K MGMT CD34+ Cells. The transduced cells are a biological product and production is detailed in the Cellular Therapy Lab standard operating procedures and IND 14099

  • O6-benzylguanineDrug

    Also called BG

    O6BG is a low molecular-weight purine analog which selectively and irreversibly inactivates the DNA-repair enzyme, O6- alkylguanine DNA-alkyltransferase.

  • Photon Based RadiotherapyRadiation

    Standard of care, photon-based radiotherapy (60Gy in 30 fractions) will be performed in both arms without concomitant TMZ between to 6 weeks post-operatively. Radiotherapy will be performed at UH-SCC.

  • temozolomideDrug

    Also called TMZ

    Temozolomide is not directly active but undergoes rapid non-enzymatic conversion at physiologic pHto the reactive compoundMTIC. The cytotoxicity of MTIC is thought to be primarily due to alkylationof DNA. Alkylation (methylation) occurs mainly at the O6 and N7 positions of guanine

  • FilgrastimDrug

    Also called G-CSF,Granulocyte-Colony Stimulating Factor

    Filgrastim is a 175 amino acid protein manufactured by recombinant DNA technology. Endogenous filgrastim is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells, which regulates the production of neutrophils within the bone marrow.

  • carmustineDrug

    Also called BCNU,bis-chloronitrosourea

    BCNU is a lipid soluble agent which has alkylating properties, plus an isocyanate metabolite which interferes with DNA and RNA synthesis.

Study groups in NCT05052957
Study groupRoleWhat they receive
stem cell mobilization after radiation therapyExperimentalParticipants at University Hospitals-Seidman Cancer Center (UH-SCC) will receive stem cell mobilization after 6 weeks of standard of care (SOC) radiotherapy. Followed by SOC chemotherapy.
Receives: Biological: P140K-MGMT; Drug: O6-benzylguanine; Radiation: Photon Based Radiotherapy; Drug: temozolomide; Drug: Filgrastim; Drug: carmustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of participants able to complete treatment

    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.

    Measured: 10 years after start of study

  2. Incidence of adverse events

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

    Measured: Up to 30 days post-treatment

  3. Overall Survival

    Median overall survival in months.

    Measured: Up to 15 years post-treatment

Secondary outcomes (5)

  1. Myelosuppression

    To determine what proportion of patients who receive P140K MGMT transduced CD34 cells tolerate BG and dose escalated TMZ without myelosuppression.

    We will report % of patients who suffer grade I-5 SAES related to myelosuppression.

    Measured: 5 years

  2. Detection of P140K transduced BG and TMZ resistant cells

    % of patients with detectable P-140K-MGMT

    Measured: 5 years

  3. Enrichment of P140K-MGMT

    What % of patients have enrichment of P140K-MGMT.

    Measured: 5 years

  4. Tumor Response using imaging

    Tumor response assessed via iRANO criteria

    Measured: 5 years

  5. PFS using imaging

    PFS measured from the date of initial histological diagnosis to progression (as defined above), death, last contact, or last tumor assessment before the start of further anti-tumor therapy

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start20 Jan 2023
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05052957
Sponsor's protocol ID
CASE5320
Other IDs
1U01CA236215-01
Acronym
hSTAR GBM
Status last verified
Sep 2026
First submitted
13 Sep 2021
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie or influence the results observed from the study.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing P140K-MGMT, O6-benzylguanine and Photon Based Radiotherapy in people with Glioblastoma Multiforme and Glioblastoma Multiforme, Adult, run by Leland Metheny at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melissa Bratley, RN (1-800-641-2422, CTUreferral@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of participants able to complete treatment (time frame: 10 years after start of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05052957.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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