ClinicalTrials.gov
ClinicalTrials.gov Menu

Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03477110
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Temozolomide Radiation: Radiation Therapy Device: NovoTTF-200A Device Procedure: Tumor Treating Fields Therapy Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the safety and toxicity of combination chemoradiotherapy with NovoTTF-200A device (Optune) treatment in newly diagnosed glioblastoma.

SECONDARY OBJECTIVES:

I. To determine the median progression-free survival of patients with newly diagnosed glioblastoma treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune.

II. To evaluate the median overall survival, 1-year overall survival, and event-free survival.

III. Collect tumor O(6)-Methylguanine-DNA-methyltransferase (MGMT) methylation status and isocitrate dehydrogenase (IDH) mutation status.

IV. To evaluate the level of circulating tumor deoxyribonucleic acid (DNA) in glioblastoma patient serum during treatment.

V. To evaluate the quality of life of patients treated with radiotherapy with concurrent and adjuvant temozolomide plus Optune.


Study Type : Interventional
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SPARE—Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (NovoTTF, Optune) for Patients With Glioblastoma: A Pilot Study
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : March 17, 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (temozolomide, radiation, NovoTTF-200A device)
Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: Temozolomide
Given PO
Other Names:
  • 362856
  • Temcad
  • Temodal
  • Methazolastone
  • Temodar

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • RT

Device: NovoTTF-200A Device
Undergo tumor treatment fields therapy using NovoTTF-200A device
Other Name: Optune

Procedure: Tumor Treating Fields Therapy
Undergo tumor treatment fields therapy using NovoTTF-200A device
Other Name: Alternating Electric Field Therapy




Primary Outcome Measures :
  1. NovoTTF-200A device discontinuation rate due to skin toxicity [ Time Frame: Up to 30 days after finishing chemoradiation treatment ]
    Discontinuation events are defined as the discontinuation of NovoTTF-200A device for > 7 consecutive days due to skin toxicity of grade 3 or higher. For discontinuation rates, the method of Atkinson and Brown will be used to allow for the two-stage design. Descriptive analysis will be performed on the acute toxicity data.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: From enrollment up to 1 year ]
    Will be evaluated using the Kaplan-Meier method.

  2. Overall survival [ Time Frame: From enrollment up to 1 year ]
    Will be evaluated using the Kaplan-Meier method.

  3. Event-free survival [ Time Frame: From enrollment up to 1 year ]
    Will be evaluated using the Kaplan-Meier method.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pathology confirmed newly diagnosed World Health Organization (WHO) grade IV glioma
  • Karnofsky performance status (KPS) ≥ 60
  • Patients must have recovered from the effects of surgery per treating physician's judgment; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 14 days must have elapsed prior to the day of protocol treatment
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3
  • Platelets ≥ 100,000 cells/mm^3
  • Hemoglobin ≥ 9.0 g/dl
  • Creatinine clearance > 30 mL/min
  • Bilirubin < 2.0 mg/dL
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3 x upper limit of normal range
  • Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose of temozolomide
  • Is able to have magnetic resonance imaging (MRI) with contrast of the brain
  • All subjects must be able to comprehend and sign a written informed consent document

Exclusion Criteria:

  • Infratentorial disease (defined as glioblastoma [GBM] derived from cerebellum or brainstem)
  • Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
  • A skull defect (such as, missing bone with no replacement)
  • Women of childbearing potential who are pregnant or breastfeeding
  • Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema)
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigator
  • Prior radiation treatment to the brain
  • No prior treatment with temozolomide
  • Known hypersensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
  • Known active collagen vascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477110


Contacts
Contact: Wenyin Shi, MD 215-955-6702 wenyin.shi@jefferson.edu

Locations
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Wenyin Shi, MD    215-955-6702    wenyin.shi@jefferson.edu   
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
NovoCure Ltd.
Investigators
Principal Investigator: Wenyin Shi, MD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03477110     History of Changes
Other Study ID Numbers: 17P.346
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Glioma
Glioblastoma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents