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Alkylating agents
Stem Cell Rescue Therapy for Glioblastoma (hSTAR GBM Trial)
Phase 2
Recruiting
Led By Leland Metheny, MD
Research Sponsored by Leland Metheny
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years post-treatment
Awards & highlights
No Placebo-Only Group
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).
Who is the study for?
This trial is for adults aged 18-70 with newly diagnosed, supratentorial glioblastoma or gliosarcoma who've had a significant portion of their tumor surgically removed. They should have an expected survival of at least 12 weeks, be in good physical condition (ECOG 0-1 or Karnofsky ≥70), and not have received prior chemotherapy for GBM. Participants must not have certain genetic mutations (unmethylated MGMT without IDH1/IDH2 mutation) and should be stable enough to undergo an autologous transplant.
What is being tested?
The study tests the effectiveness of P140K MGMT hematopoietic stem cells combined with O6-benzylguanine, temozolomide, and carmustine chemotherapy on patients post-surgery. It aims to make bone marrow more resistant to chemo so higher doses can target tumor cells while sparing the bone marrow.
What are the potential side effects?
Potential side effects include those typical of chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, organ inflammation from drug reactions, and potential complications from stem cell transplantation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Overall Survival
Percent of participants able to complete treatment
Secondary study objectives
Detection of P140K transduced BG and TMZ resistant cells
Enrichment of P140K-MGMT
Myelosuppression
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: stem cell mobilization after radiation therapyExperimental Treatment6 Interventions
Participants 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
O6-benzylguanine
1999
Completed Phase 2
~240
Filgrastim
2000
Completed Phase 3
~3690
temozolomide
2008
Completed Phase 2
~1060
carmustine
1994
Completed Phase 3
~2750
Find a Location
Who is running the clinical trial?
Leland MethenyLead Sponsor
5 Previous Clinical Trials
64 Total Patients Enrolled
Andrew Sloan, MDLead Sponsor
1 Previous Clinical Trials
73 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,564 Total Patients Enrolled
330 Trials studying Glioblastoma
23,371 Patients Enrolled for Glioblastoma
Leland Metheny, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
8 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 tumor does not have IDH1 or IDH2 mutations.
Research Study Groups:
This trial has the following groups:- Group 1: stem cell mobilization after radiation therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Glioblastoma Patient Testimony for trial: Trial Name: NCT05052957 — Phase 2