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Stem Cell Rescue Therapy for Glioblastoma (hSTAR GBM Trial)
hSTAR GBM Trial Summary
This trial is studying the effect of giving P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine to people with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor (resected).
hSTAR GBM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowhSTAR GBM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.hSTAR GBM Trial Design
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Who is running the clinical trial?
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- I have been cancer-free or in remission for at least 2 years.I am between 18 and 75 years old.I can provide 10 slides or a sample of my tumor for testing.I haven't had chemotherapy or bone marrow transplant before my brain cancer diagnosis.All my stitches have been removed.I have severe lung problems or diseases that cause symptoms.I have a confirmed diagnosis of glioblastoma or gliosarcoma and had most of the tumor surgically removed recently.A transplant doctor has approved me for a self-donor transplant.I have tested positive for HIV.I have had Hepatitis B or C, or severe liver inflammation.My tumor does not have IDH1 or IDH2 mutations.I haven't had bone marrow-suppressing treatment or stem cell transplant before my brain cancer diagnosis, nor chemotherapy for it.I am mentally capable of understanding and consenting to participate.I have heart failure with an LVEF less than 40%.I have a history of irregular heartbeats.I am fully active or able to carry out light work.I am on a low dose of steroids or reducing my dose, for at least a week.I am not planning to undergo short-course radiation treatment.My blood, liver, and kidney functions are all within normal ranges.My cancer has unmethylated MGMT.I had surgery for a brain tumor with most of it removed and am within six weeks post-surgery.I am willing and able to understand and agree to the study's procedures.I have a condition that weakens my immune system.I do not have any current infections.I am fully active or able to carry out light work.I am between 18 and 70 years old.My cancer has an unmethylated MGMT gene.My tumor does not have IDH1 or IDH2 mutations.
- Group 1: stem cell mobilization after radiation therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what illnesses is O6-benzylguanine typically prescribed?
"O6-benzylguanine is commonly employed to halt the advancement of maladies, and can be prescribed for leukemia, myelocytic acute illnesses, advanced directives, or ependymomas."
Is the clinical trial open to minors?
"This trial is limited to individuals aged 18-70 years old. Meanwhile, there are 160 trials open for those under the legal age of consent and 702 clinical studies available for participants over 65."
Are there previous trials of O6-benzylguanine that can inform this research?
"The City of Hope Comprehensive Cancer Center first investigated O6-benzylguanine in 1997, and since then has completed 876 trials. Currently, there are 388 active clinical studies with a significant number located in Bethesda, Maryland."
To what extent can O6-benzylguanine be deemed safe for patients?
"Though it is still in the Phase 2 stage, there are some indications that O6-benzylguanine exhibits a good safety profile. Our team at Power has assigned this medication a score of 2 accordingly."
What primary objective is this research attempting to fulfill?
"The primary purpose of this long-term trial, lasting up to 15 years post-treatment, is the evaluation of participant's ability to complete treatment. In addition, secondary outcomes include detection levels of P140K transduced cells and TMZ resistant cells (as a percentage), progression free survival measured from initial diagnosis until death or further therapy begins as well as tumor response assessed via iRANO criteria."
Am I eligible to join this research program?
"This clinical experiment is looking for 16 people with glioblastoma ranging in age from 18 to 70. Essential requirements include: historologically confirmed, newly diagnosed supratentorial glioblastomas or gliosarcomas; gross total resection of >85% of the visible tumor on MRI; absence of IDH1 and/or IDH2 mutations on local testing; ECOG performance status 0-1 or Karnofsky ≥70 score; no prior chemotherapy treatment including Gliadel BCNU wafers, etc.; life expectancy exceeding 12 weeks; serum creatinine ≤ 2mg/dl,"
What is the current participant population for this research initiative?
"At the present moment, this trial is not accepting participants. Initially published on December 15th 2022 and recently modified on July 4th 2022, interim data indicates that there are currently 444 clinical trials for glioblastoma and 388 studies involving O6-benzylguanine recruiting patients."
Are there still openings to participate in this medical experiment?
"Clinicaltrials.gov reveals that the recruitment for this trial, which was first made public on December 15th 2022, is no longer active. However, there are 830 other medical studies currently accepting participants."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What site did they apply to?
Why did patients apply to this trial?
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