Trial Search Results

Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma

The purpose of this study is to determine the safety and efficacy of the combination therapy of TTFields + SRS+ Temozolomide (TMZ) for newly diagnosed glioblastoma (GBM).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: NovoCure Ltd.

Stanford Investigator(s):

Intervention(s):

  • Device: Optune
  • Drug: Gadolinium
  • Drug: Temozolomide
  • Radiation: Stereotactic radiosurgery (SRS)

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Samantha Wong
Not Recruiting