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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
Patients aged 18-75 years
No myelosuppressive chemotherapy or hematopoietic cell transplantation prior to the diagnosis of GBM and no prior chemotherapy for GBM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years post-treatment
Awards & highlights

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).

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.Check my eligibility
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.See study design
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.

hSTAR GBM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I haven't had chemotherapy or bone marrow transplant before my brain cancer diagnosis.
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All my stitches have been removed.
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I do not have any current infections.
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A transplant doctor has approved me for a self-donor transplant.
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My tumor does not have IDH1 or IDH2 mutations.
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I am fully active or able to carry out light work.
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I am not planning to undergo short-course radiation treatment.
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My cancer has unmethylated MGMT.

hSTAR GBM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Overall Survival
Percent of participants able to complete treatment
Secondary outcome measures
Detection of P140K transduced BG and TMZ resistant cells
Enrichment of P140K-MGMT
Myelosuppression
+2 more

hSTAR GBM 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
~3670
temozolomide
2008
Completed Phase 2
~1060
carmustine
1994
Completed Phase 3
~2750

Find a Location

Who is running the clinical trial?

Leland MethenyLead Sponsor
4 Previous Clinical Trials
54 Total Patients Enrolled
Andrew Sloan, MDLead Sponsor
1 Previous Clinical Trials
73 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,331 Total Patients Enrolled
316 Trials studying Glioblastoma
22,652 Patients Enrolled for Glioblastoma

Media Library

Carmustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05052957 — Phase 2
Glioblastoma Research Study Groups: stem cell mobilization after radiation therapy
Glioblastoma Clinical Trial 2023: Carmustine Highlights & Side Effects. Trial Name: NCT05052957 — Phase 2
Carmustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05052957 — Phase 2
Glioblastoma Patient Testimony for trial: Trial Name: NCT05052957 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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,"

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
University Hospitals Cleveland Medical Center

Why did patients apply to this trial?

I have had a total tumor resection in 4/2021. Did the chemo and radiation as planned, and last chemo was 12/28/21, my sons birthday. Have lived a very active and healthy lifestyle to keep the GBM away. Continued the MRI check ups every 2 months. Today 1/20/23 there is a finding on my MRI. 1.5x1.6 “high grade” glial tumor. I want to do whatever I can to stop the growth.
PatientReceived 1 prior treatment
~2 spots leftby Jun 2024