Palo Alto, California 94304

  • Glioblastoma

Purpose:

This phase I trial studies how well [18F]DASA-23 and positron emission tomography (PET) scan work in evaluating pyruvate kinase M2 (PKM2) expression in patients with intracranial tumors or recurrent glioblastoma and healthy volunteers. PKM2 regulates brain tumor metabolism, a key factor in glioblastoma growth. [18F]DASA-23 is a radioactive substance with the ability to monitor PKM2 activity. A PET scan is a procedure in which a small amount of a radioactive substance, such as [18F]DASA-23, is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the substance is used. Tumor cells usually pick up more of these radioactive substances, allowing them to be found. Giving [18F]DASA-23 with a PET scan may help doctors evaluate PKM2 expression in healthy volunteers and in participants with intracranial tumors or recurrent glioblastoma.


Study summary:

PRIMARY OBJECTIVES: I. Determine whether the fluorine F 18 DASA-23 ([18F]DASA 23) PET scan signal change from pre-therapy to one week after initiation of therapy can predict the tumor's responsiveness to therapy and 6 month progression free survival (PFS6), in suspected recurrent glioblastoma. SECONDARY OBJECTIVES: I. Determine the sensitivity, specificity, and accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors. II. Determine whether the [18F]DASA-23 PET scan signal change from pre therapy to one week after initiation of therapy can predict progression free survival (PFS) and overall survival (OS), in suspected recurrent glioblastoma. OUTLINE: Participants are assigned to 1 of 4 groups. GROUP I: Healthy volunteers receive [18F]DASA-23 intravenously (IV) and undergo brain PET scan over 15 minutes and 4 vertex-to-toe PET scans over 30 minutes each. GROUP II: Intracranial tumor participants receive [18F]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes. GROUP III: Subjects with glioblastoma will receive [18F]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes. Participants undergo second PET scan 7 days after the initiation of therapy. GROUP IV: Healthy volunteers will undergo the same procedures as the healthy volunteers in Group I with the following exceptions: Group IV healthy volunteers will undergo a 60-minute PET/MRI brain scan instead of a 15-minute PET/MRI brain scan. Group IV healthy volunteers will not undergo any vertex-to-toe PET scans. After completion of study treatment, intracranial tumor and recurrent glioblastoma participants are followed up every 3 months for 12 months.


Criteria:

Inclusion Criteria: - Absolute neutrophil count (ANC) >= 1.5 X 10^9/L without (w/o) myeloid growth factor support for 7 days preceding lab assessment, obtained within 14 days prior to PET scan - Hemoglobin (Hgb) >= 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb is corrected to >= 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan, obtained within 14 days prior to PET scan - Platelet count >= 100 X 10^9/L w/o blood transfusions for 7 days preceding lab assessment, obtained within 14 days prior to PET scan - Bilirubin = < 1.5 X upper limit of normal (ULN) except for patients (pts) with (w/) documented history of Gilbert?s disease, obtained within 14 days prior to PET scan - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 X ULN, obtained within 14 days prior to PET scan - Alkaline phosphatase (AP) =< 3 X ULN, obtained within 14 days prior to PET scan - Women of childbearing potential (WCBP): negative serum pregnancy test, obtained within 14 days prior to PET scan - Karnofsky performance status (KPS) >= 60 (Parts 2 [intracranial tumor patients] and 3 [recurrent glioblastoma (GBM) patients] ONLY) - Ability to understand and the willingness to sign a written informed consent document - (Part 2, intracranial tumor patients ONLY): Radiographical or pathological evidence of an intracranial tumor - (Part 3, suspected GBM patients ONLY): Any patient with histopathologically proven GBM who, on a standard of care surveillance brain magnetic resonance imaging (MRI), has an imaging change suspicious for GBM recurrence, and whose treatment plan for the recurrence does not include surgery - (Part 3, suspected GBM patients ONLY): Life expectancy of >= 6 months Exclusion Criteria: - Known allergy to adhesive tapes or other skin adhesives used in medical care - Known cirrhosis diagnosed with Child Pugh class A or higher liver disease - Severe/uncontrolled inter current illness within the previous 28 days prior to PET scan - Patients who have implantable devices that are contraindicated for MRI - Bleeding disorder - Any other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation - Additional exclusion criterion for healthy volunteers (Part 1 and Part 4 ONLY) - Prior or current malignancy - Known kidney disease - Pregnant or nursing participants - History of allergic reactions to gadolinium-based MRI contrast agent - (Part 2, intracranial tumor patients ONLY): Other chemotherapy (besides what is being used to treat the intracranial tumor) - (Part 3, suspected recurrent GBM patients ONLY): Has already begun non surgical therapy for any recurrence, prior to the first [18F]DASA 23 PET/MRI scan


NCT ID:

NCT03539731


Primary Contact:

Principal Investigator
Guido A Davidzon, MD
Stanford Cancer Institute Palo Alto


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States

Lewis Naya
Phone: 650-724-9363
Email: lnaya@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 23, 2021

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