Study on Using Stem Cell Rescue and Chemotherapy for Treating Glioblastoma or Gliosarcoma

Sponsor: Leland Metheny

Sponsor score: 40

ClinicalTrials ID:NCT05052957

Provider View

This clinical trial is exploring a new treatment approach for patients with glioblastoma or gliosarcoma who have recently had surgery to remove most or all of their brain tumor. The study combines chemotherapy with a special gene therapy to help protect the bone marrow, allowing for higher doses of chemotherapy to target the cancer more effectively.

Patient Parameters

Program Overview

This phase II study is testing a new treatment for patients with glioblastoma or gliosarcoma, a type of brain cancer, who have had surgery to remove the tumor. The treatment involves using chemotherapy drugs, along with a gene therapy that makes the bone marrow more resistant to the effects of chemotherapy. This allows doctors to increase the chemotherapy dose to kill more cancer cells while protecting the bone marrow.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with glioblastoma or gliosarcoma in the upper part of the brain and have had surgery to remove most or all of the tumor.
  • Must not have more than 1 cm of tumor left after surgery.
  • Tumor must not have certain genetic mutations (unmethylated MGMT and no IDH1 or IDH2 mutations).
  • Aged between 18 and 75 years.
  • Good overall health with a performance status score of 0 or 1.
  • No previous chemotherapy or bone marrow transplant for glioblastoma.
  • Expected to live at least 12 more weeks.
  • No plans for a specific type of radiation therapy.
  • Adequate blood cell counts and organ function based on specific tests.
  • Stable or decreasing steroid use before joining the study.
  • Women of childbearing potential must use contraception.
  • Must understand and agree to the study requirements.
  • All surgical stitches must be removed before joining the study.
  • Must be considered stable by a doctor.
  • Must be evaluated as a candidate for a bone marrow transplant.
  • No active infections.
  • Must provide a tumor sample for further study.
  • Negative tests for Hepatitis B, C, and HIV.

Exclusion Criteria

  • Any condition that weakens the immune system or other serious medical issues.
  • Known HIV infection due to potential risks with the treatment.
  • Pregnant or breastfeeding women due to risks to the baby.
  • Severe lung problems or low oxygen levels.
  • Heart problems, including recent heart attacks or heart failure.
  • History of irregular heartbeats.
  • Cannot have MRI scans or allergic to MRI contrast agents.
  • Active drug or alcohol abuse.
  • Previous cancer diagnosis unless in remission for at least 2 years.
  • Mental health issues preventing understanding of the study.
  • History of severe liver disease or hepatitis.

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