Stem Cell Rescue Therapy for Glioblastoma
(hSTAR GBM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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. Placing P140K MGMT, a gene that has been created in the laboratory into bone marrow making the bone more resistant to chemotherapy, allowing intra-patient dose escalation which kills more tumor cells while allowing bone marrow to survive.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have had prior chemotherapy for glioblastoma and that post-operative steroids should be tapered to a certain level before enrollment.
Is Stem Cell Rescue Therapy for Glioblastoma safe for humans?
Research shows that treatments involving carmustine (BCNU) and temozolomide (TMZ) can cause myelosuppression (a decrease in bone marrow activity leading to fewer blood cells) as a significant side effect. The combination of these drugs has been tested in humans, and while it is feasible, it may lead to blood-related toxicities, especially with long-term use.12345
What makes the Stem Cell Rescue Therapy for Glioblastoma unique?
This treatment is unique because it combines gene therapy with chemotherapy, using a modified gene (MGMT-P140K) to protect healthy cells from the toxic effects of chemotherapy drugs like Carmustine and Temozolomide, allowing for higher doses to be used against the tumor while reducing side effects.14678
What data supports the effectiveness of the drug combination used in the Stem Cell Rescue Therapy for Glioblastoma?
Research shows that temozolomide (TMZ) has high response rates in treating certain brain tumors, and combining carmustine (BCNU) with O6-benzylguanine (BG) has been studied for its activity in treating resistant malignant gliomas. These findings suggest potential effectiveness in glioblastoma treatment.19101112
Who Is on the Research Team?
Leland Metheny, MD
Principal Investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive 6 weeks of standard of care radiotherapy
Stem Cell Mobilization
Participants undergo stem cell mobilization after radiation therapy
Chemotherapy
Participants receive chemotherapy with O6-benzylguanine, temozolomide, and carmustine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carmustine
- Filgrastim
- O6-benzylguanine
- P140K-MGMT
- Photon Based Radiotherapy
- Temozolomide
Carmustine is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Leland Metheny
Lead Sponsor
Andrew Sloan, MD
Lead Sponsor
National Cancer Institute (NCI)
Collaborator