Clinical trial 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?
An investigational cellular therapy being studied as a potential treatment for glioblastoma multiforme. It is designed to introduce a modified MGMT gene into hematopoietic stem cells to make bone marrow more resistant to chemotherapy, allowing higher chemo doses to target the tumor.
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 study aims to find out if adding a special gene to bone marrow cells allows doctors to use higher doses of chemotherapy to fight the tumor without damaging the patient's bone marrow.
- Who it's for
- The study is looking for adults with glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the tumor.
- What's involved
- Participants will receive chemotherapy drugs and a treatment that modifies their bone marrow cells to make them more resistant to the drugs.
- Time commitment
- The source text does not specify the total duration of the study or the number of required visits.
- 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 and older
You may be able to join if
- Participants with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone tumor resection are...
- 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.
You likely can't join if
- 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.
- 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.
See the full eligibility criteria
- Participants with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone tumor resection are eligible up to 35 days postoperatively.
- 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.
- No plan for hypofractionated radiation therapy
- 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)
- 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.
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.