Using stem cells and chemotherapy to treat brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effects of P140K MGMT hematopoietic stem cells combined with chemotherapy agents O6-benzylguanine, temozolomide, and carmustine in patients with recently resected supratentorial glioblastoma or gliosarcoma. The approach aims to enhance the resistance of bone marrow to chemotherapy, allowing for higher doses to be administered while protecting the bone marrow. Participants must have undergone significant tumor resection and meet specific genetic criteria related to their tumor. The study evaluates the safety and efficacy of this treatment regimen in improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone tumor resection are eligible up to 35 days postoperatively. Participants with primarily infratentorial disease, or with multifocal, or leptomeningeal dissemination of disease will be excluded. In general, participants will not have \> 1 cm residual measurable or evaluable disease after surgical tumor resection.
* Participant must have unmethylated MGMT
* Absence of IDH1 or IDH2 mutation on tumor tissue by a CLIA-approved immunohistochemistry or DNA sequencing test on local testing.
* Participants aged 18 years or older.
* ECOG performance status 0-1or Karnofsky ≥ 70.
* Life expectancy of at least 12 weeks.
* No plan for hypofractionated radiation therapy
* Adequate hematologic and hepatic function:

  * CBC/differential obtained within 28 days prior to registration:

    * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Note: the use of G-CSF or other intervention to achieve Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 is acceptable)
    * Platelets ≥ 50,000 cells/mm3 (Note: the use of transfusion or other intervention to achieve Platelets ≥ 50,000 cells/mm3 is acceptable)
    * Hemoglobin ≥ 9.0 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥9.0 g/dl is acceptable)
  * Adequate hepatic function within 28 days prior to registration:

    * Bilirubin ≤ 3 ULN
    * ALT and AST ≤ 3 x ULN
* Participants of child-bearing potential must agree to use single barrier contraception from time of trial entry to completion of the last cycle of chemotherapy.
* Must be willing and able to understand and provide informed consent.
* Participant must be considered to be clinically stable.
* The participant will be identified as a candidate for an autologous transplant via an evaluation by a transplant physician per standard of care.
* No evidence of active infection.
* Participant must have the ability to understand and willingness to sign an informed consent document.

Exclusion Criteria:

* Any known medical or hereditary condition associated with immunosuppression; or other medical illness, which may jeopardize participant safety.
* Pregnant or lactating women. There is data to indicate that BCNU and TMZ is teratogenic and carcinogenic. Thus, its use in pregnant women would confer unnecessary risk to the fetus.
* Participants with a corrected DLCO or FEV1 \< 50% of predicted.
* Participants with known diagnosis heart failure or cardiac insufficiency and an LVEF of \< 40%.
* Inability to undergo repeated MRI evaluation; or allergy or intolerance of Gadoliniumcontaining contrast agent.
* Active illicit drug use or diagnosis of active alcoholism.
* Prior diagnosis of any malignant disease with the exception of non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder, prostate, or breast, unless the participant has been disease-free/in remission for ≥2 years prior to date of study enrollment.
* Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness.
* Serologic status reflecting active hepatitis B or C infection. Individuals that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive individuals will be excluded).

Where it's running

• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Leland Metheny, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
• Study coordinator: Melissa Bratley, RN
• Email: CTUreferral@uhhospitals.org
• Phone: 1-800-641-2422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.