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New treatment option for Glioblastoma Multiforme
Official title hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
ClinicalTrials.gov ID: NCT05052957
What this study is testing
What is P140K-MGMT?
P140K-MGMT is an investigational medicine, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone gross total tumor resection or...
- 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.
You likely can't join if
- 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+...
- Pregnant or lactating women. There is data to indicate that BCNU and TMZ is teratogenic and carcinogenic. Thus, its use in pregnant women would...
- Patients with symptomatic pulmonary disease and other severe co-morbid respiratory conditions, including patients with active pulmonary infection...
- Patients with known diagnosis heart failure or cardiac insufficiency and an LVEF of \< 40%. History of acute coronary event including MI within 6...
- Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmiaor bradycardia.Inability to undergo repeated MRI evaluation; or...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.