Glioblastoma Clinical Trial
Official title:
A Phase I Study of [18F]DASA-23 as a PET Tracer for Evaluating Pyruvate Kinase M2 (PKM2) Expression in Healthy Volunteers and in Patients With Intracranial Tumors
Verified date | February 2024 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Age =18 years old. 2. Adequate organ function (obtained within 14 days prior to PET scan [Part 1, Part 2, and Part 3 ONLY] or within 28 days prior to PET scan [Part 4 ONLY]) as evidenced by: 1. ANC = 1.5 X 10^9/L w/o myeloid growth factor support for 7 d preceding lab assessment 2. 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 3. Platelet count = 100 X 10^9/L w/o blood transfusions for 7 d preceding lab assessment 4. Bilirubin = 1.5 X ULN except for pts w/ documented history of Gilbert's disease 5. ALT and AST = 2.5 X ULN 6. Alkaline phosphatase (AP) = 3 X ULN 7. Women of childbearing potential (WCBP): negative serum pregnancy test 3. Ability to stand up and climb two steps with minimal assistance. 4. Ability to understand and the willingness to sign a written informed consent document. 5. (Part 2, intracranial tumor patients ONLY) (a) Radiographical or pathological evidence of newly-diagnosed intracranial tumor that is status-pre surgical resection, or (b) Radiographical or pathological evidence of progressive/recurrent intracranial tumor, (c) Question of pseudoprogression vs. true progression on most recent standard-of-care brain MRI, or (d) Evidence on the most recent standard-of-care brain MRI scan of intracranial metastasis/metastases in a patient with known extracranial primary cancer. 6. (Part 3, GBM patients ONLY) Any patient with at least a 1cm3 contrast-enhancing lesion suspicious for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) on a standard-of-care (SOC) brain MRI scan. If the patient undergoes a biopsy or resection for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) then the remaining contrast-enhancing lesion is at least 1cm3 in size on the post-operative scan. 7. (Part 3, GBM patients ONLY) Life expectancy of = 6 months. Exclusion Criteria: 1. Known allergy to adhesive tapes or other skin adhesives used in medical care 2. Subjects with the following co-morbid disease or incurrent illness: 1. With known cirrhosis diagnosed with Child-Pugh Class A or higher liver disease. 2. Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan 3. Patients who have implantable devices that are contra-indicated for MRI 4. Bleeding disorder 5. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation. 6. (Healthy volunteers ONLY - Part 1 and Part 4) prior or current malignancy 7. (Healthy volunteers ONLY - Part 1 and Part 4) known kidney disease 3. Pregnant or nursing participants 4. History of allergic reactions to gadolinium-based MRI contrast agent 5. (Part 2, intracranial tumor patients ONLY) Other chemotherapy (besides what is being used to treat the intracranial tumor) 6. (Part 3, GBM patients ONLY) Has already begun therapy, prior to the first of two [18F]DASA-23 PET/MRI scans. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University, School of Medicine | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Guido A. Davidzon, MD, SM |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in [18F]DASA-23 PET scan signal in patients with suspected recurrent glioblastoma | Response to treatment is based on the response assessment in neuro-oncology (RANO) criteria. Each patient will be dichotomized into responding (yes) or not responding (no) to treatment based on RANO criteria. The [18F]DASA-23 PET scan signal will be calculated according to the European Organization for Research and Treatment of Cancer (EORTC) response criteria guidelines and reported as median and range, both for the entire cohort as well as separately for the responder and non-responder subgroups. The Mann-Whitney test of [18F]DASA-23 PET scan signal between responders and non-responders will be performed. | From pre-treatment to one week after initiation of treatment | |
Secondary | Sensitivity of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors. | Sensitivity will be reported as a percentage with 95% confidence interval. | Time of the [18F]DASA-23 PET scan | |
Secondary | Specificity of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors. | Specificity will be reported as a percentage with 95% confidence interval | Time of the [18F]DASA-23 PET scan | |
Secondary | Accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors. | Accuracy will be reported as a percentage with 95% confidence interval. | Time of the [18F]DASA-23 PET scan | |
Secondary | Progression-free survival in patients with suspected recurrent glioblastoma | The percent change in SUV from the pre-treatment [18F]DASA-23 PET scan to the post-treatment [18F]DASA23 PET scan will be calculated. Patients will be divided into two groups based on whether their percent change in SUV is above or below the median. Kaplan-Meier curves for the two groups will be plotted and a log-rank test for difference in progression-free survival will be performed. A Cox proportional-hazards regression of progression-free survival on group will be performed. Progression-free survival will be reported as median survival time, with range. | Time from diagnosis up to 1 year | |
Secondary | Overall survival in patients with suspected recurrent glioblastoma | The percent change in SUV from the pre-treatment [18F]DASA-23 PET scan to the post-treatment [18F]DASA23 PET scan will be calculated. Patients will be divided into two groups based on whether their percent change in SUV is above or below the median. Kaplan-Meier curves for the two groups will be plotted and a log-rank test for difference in overall survival will be performed. A Cox proportional-hazards regression of overall survival on group will be performed. Overall survival will be reported as median survival time, with range. | From time of initial diagnosis up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05664243 -
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT02768389 -
Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
|
Early Phase 1 | |
Recruiting |
NCT05635734 -
Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT03679754 -
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
|
Phase 1 | |
Completed |
NCT01250470 -
Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
|
Phase 1 | |
Terminated |
NCT03927222 -
Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
|
Phase 2 | |
Recruiting |
NCT03897491 -
PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT03587038 -
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
|
Phase 1 | |
Completed |
NCT01922076 -
Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
|
Phase 1 | |
Recruiting |
NCT04391062 -
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT03661723 -
Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT02655601 -
Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
|
Phase 2 | |
Completed |
NCT02206230 -
Trial of Hypofractionated Radiation Therapy for Glioblastoma
|
Phase 2 | |
Completed |
NCT03493932 -
Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
|
Phase 1 | |
Terminated |
NCT02709889 -
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
Completed |
NCT03018288 -
Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
|
Phase 2 | |
Not yet recruiting |
NCT04552977 -
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma
|
Phase 2 | |
Withdrawn |
NCT03980249 -
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|
Early Phase 1 | |
Terminated |
NCT02905643 -
Discerning Pseudoprogression vs True Tumor Growth in GBMs
|