- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474353
Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma
A Phase 1 Study of Tumor Treating Fields With 5 Day Hypofractionated Stereotactic Radiosurgery and Concurrent and Maintenance Temozolomide in Newly Diagnosed Glioblastoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective:
Determine the safety of Tumor Treating Fields (TTFields) started concurrently with 5 fraction stereotactic radiosurgery (SRS) and temozolomide for newly diagnosed glioblastoma. secondary objective: Efficacy for the combination of TTFields started concurrently with 5
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Aniket Pratapneni
- Phone Number: 650-723-3110
- Email: apratap1@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94304
- Recruiting
- Stanford University
-
Principal Investigator:
- Scott G Soltys
-
Contact:
- Aniket Pratapneni
- Phone Number: 650-723-3110
- Email: apratap1@stanford.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histopathologically proven newly diagnosed glioblastoma (GBM, WHO Grade IV) or molecular GBM of lower grade that will be treated as per glioblastoma (defined as IDH wild type, 1p19q not co deleted)
- Age ≥ 18 years
- A maximum tumor target diameter of less than 5 cm on the post operative MRI used for SRS planning (a 5 mm margin is added in the radiotherapy planning process, yielding a maximum diameter of the planning target volume (PTV) of less than 6 cm). If the maximum diameter is greater than 5 cm, the subject is still eligible if the PTV is less than 113 cm3 which is the volume of a 6 cm diameter sphere.
Adequate organ function (obtained within 14 days prior to Day 0) as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L without myeloid growth factor support for 7 days preceding the lab assessment
- Hemoglobin (Hgb) ≥ 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if hemoglobin is corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion prior to Day 0
- Platelet count ≥ 100 × 109/L without blood transfusions for 7 days preceding the lab assessment
- Bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with documented history of Gilbert's disease
- Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Alkaline phosphatase (AP) ≤ 3 × ULN
- Women of childbearing potential (WCBP): negative serum pregnancy test (this test is required of all women unless post menopausal, defined as 12 consecutive months since last regular menses or surgically sterile)
- Ability to tolerate MRI
- Karnofsky Performance Scale (KPS) ≥ 60
- Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document.
Exclusion Criteria:
- Previous chemotherapy or radiotherapy for glioma
- Concurrent use of experimental therapies
- Known allergy to adhesive tapes or other skin adhesives used in medical care
- Known underlying skin hypersensitivity or other condition of the scalp with potential toxicity per pre treatment dermatology evaluation
Subjects with the following co morbid disease or incurrent illness:
- Subjects with known cirrhosis diagnosed with Child Pugh Class A or higher liver disease.
- Prior malignancy except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to first dose of investigational drug
- Severe/uncontrolled inter current illness within the previous 28 days prior to first day of treatment
- Subjects who have implantable devices that are contra indicated for use with TTFields
- Any other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
Subjects receiving the following medications at the time of combined TTFields and SRS:
- Pharmacotherapy for tuberculosis or HIV as these medications are known to interact with temozolomide
- Other chemotherapy, other investigational agents, or biologic agents for the treatment of cancer including antibodies (eg, bevacizumab, trastuzumab, pertuzumab), small molecules, or any investigational agent(s).
- Pregnant or nursing females will be excluded from the study
- History of inability to tolerate MRI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Novo-TTF
Day 1: Subjects will wear the Optune (TTFields device) for ≥ 18 hours/day. They will take off the device when receiving stereotactic radiosurgery and brain MRI scans. Days 1 to 8: Subjects will take oral temozolomide 75 mg/m2/day Days 2 to 8: Subjects will receive stereotactic radiosurgery (total of 35 Gy) divided equally over 5 days • After the interventional treatment, subjects will receive standard of care adjuvant chemotherapy and routine surveillance brain MRI scans. |
Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure
Gadolinium contrast medium
Other Names:
Chemotherapy agent
Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting Toxicity (DLTs)
Time Frame: 5 months
|
Dose limiting toxicities (DLTs) are defined as possibly, probably, or definitely related adverse events that are severe or medically significant, and needing topical & systemic therapy; needing surgery intervention; needing hospitalization; needing treatment interruption; or life threatening.
Late DLTs will be assessed as the number of DLTs that occur in the period from 31 days after the start of treatment through 5 months after the start of treatment.
The outcome will be reported as a number without dispersion.
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute dose limiting toxicity
Time Frame: 1 month
|
Dose limiting toxicities (DLTs) are defined as possibly, probably, or definitely related adverse events that are severe or medically significant, and needing topical & systemic therapy; needing surgery intervention; needing hospitalization; needing treatment interruption; or life threatening.
Acute DLTs will be assessed as the number of DLTs that occur in the period from the start of treatment through 30 days after the start of treatment.
The outcome will be reported as a number without dispersion.
|
1 month
|
Progression-free Survival (PFS) at 6 Months
Time Frame: 6 months
|
Progression-free survival is defined as the number of evaluable participants who, at 6 months from the date of surgical resection or biopsy (PFS6), are alive without disease progression, death, or other defined event (study withdrawal or loss to follow up).
Disease progression is defined as ≥ 25% increase in product of perpendicular diameters of the lesion; any increase in MRI T2/FLAIR lesion area from previous MRI scan; MRI detection of a new lesion; decline in clinical status not attributable to causes other than the tumor.
The outcome will be reported as the number without dispersion.
|
6 months
|
Overall Survival (OS)
Time Frame: 30 months
|
Overall survival (OS) will be assessed as the number of evaluable participants who remain alive from the date of surgical resection or biopsy.
The outcome will be reported as the number without dispersion.
|
30 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott G Soltys, Stanford Universiy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- IRB-53582 (Other Identifier: Stanford IRB)
- BRN0043 (Other Identifier: OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glioblastoma
-
Celldex TherapeuticsCompletedGlioblastoma | Gliosarcoma | Recurrent Glioblastoma | Small Cell Glioblastoma | Giant Cell Glioblastoma | Glioblastoma With Oligodendroglial Component | Relapsed GlioblastomaUnited States
-
Juan M Garcia-GomezHospital Universitario 12 de Octubre; Hospital Clínico Universitario de ValenciaRecruitingGlioblastoma | Glioblastoma Multiforme | High Grade Glioma | Astrocytoma, Grade IV | Glioblastoma, IDH-mutant | Glioblastoma, IDH-wildtype | Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype | Glioblastoma IDH (Isocitrate Dehydrogenase) MutantSpain
-
Jasper GerritsenMassachusetts General Hospital; Universitaire Ziekenhuizen KU Leuven; University... and other collaboratorsRecruitingGlioblastoma | Glioblastoma Multiforme | Glioblastoma, IDH-wildtype | Glioblastoma Multiforme, Adult | Glioblastoma Multiforme of BrainUnited States, Belgium, Switzerland, Germany, Netherlands
-
Jasper GerritsenMassachusetts General Hospital; Universitaire Ziekenhuizen KU Leuven; University... and other collaboratorsRecruitingGlioblastoma | Glioblastoma Multiforme | Recurrent Glioblastoma | Glioblastoma, IDH-wildtype | Glioblastoma Multiforme, Adult | Glioblastoma Multiforme of Brain | Astrocytoma of Brain | Astrocytoma, MalignantUnited States, Germany, Netherlands, Switzerland, Belgium
-
Leland MethenyNational Cancer Institute (NCI)RecruitingGlioblastoma Multiforme | Supratentorial Gliosarcoma | Glioblastoma Multiforme, Adult | Supratentorial GlioblastomaUnited States
-
Northwestern UniversityAgenus Inc.; CarTheraRecruitingGlioblastoma Multiforme | Gliosarcoma | Newly Diagnosed Glioblastoma | Glioblastoma, Isocitric Dehydrogenase (IDH)-WildtypeUnited States
-
University Hospital, GenevaActive, not recruitingGlioblastoma Multiforme | Glioblastoma Multiforme of Brain | Glioma of Brain | Glioblastoma, AdultSwitzerland
-
Milton S. Hershey Medical CenterRecruitingGlioblastoma | Glioblastoma Multiforme | Glioblastoma Multiforme, Adult | Glioblastoma Multiforme of BrainUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)RecruitingGlioblastoma | Astrocytoma | Recurrent Glioblastoma | MGMT-Unmethylated Glioblastoma | Glioblastoma, IDH-WildtypeUnited States
-
Milton S. Hershey Medical CenterNational Cancer Institute (NCI)RecruitingGlioblastoma | Glioblastoma Multiforme | Glioblastoma Multiforme, Adult | Glioblastoma Multiforme of BrainUnited States
Clinical Trials on Optune
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI); NovoCure Ltd.; American Lebanese Syrian Associated...RecruitingMalignant Glioma | Ependymoma | Diffuse Intrinsic Pontine GliomaUnited States
-
Saint Luke's Health SystemNovoCure Ltd.WithdrawnCentral Nervous System Neoplasms, Primary
-
Abramson Cancer Center at Penn MedicineActive, not recruiting
-
Memorial Sloan Kettering Cancer CenterUniversity of Colorado, Denver; University of Miami; Columbia University; Cedars-Sinai... and other collaboratorsActive, not recruitingBrain CancerUnited States
-
Baylor Research InstituteTerminated
-
NovoCure GmbHActive, not recruitingGlioblastoma MultiformeUnited States, United Kingdom, Israel, Germany, Japan, Canada, France, Switzerland, Belgium, Czechia, Austria
-
Hackensack Meridian HealthNovoCure Ltd.Active, not recruiting
-
University of Maryland, BaltimoreNovoCure Ltd.TerminatedBrain Tumor | RECURRENT GLIOBLASTOMAUnited States
-
Sichuan UniversityRecruiting
-
Emory UniversityNational Cancer Institute (NCI)Recruiting