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

Primary Purpose

Glioblastoma

Status

Unknown status

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Temozolomide

Radiation Therapy

NovoTTF-200A Device

Tumor Treating Fields Therapy

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. If the subject can comprehend the informed consent but is unable to sign, a LAR may sign the 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
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

Sites / Locations

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (temozolomide, radiation, NovoTTF-200A device)

Arm Description

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.

Outcomes

Primary Outcome Measures

NovoTTF-200A device discontinuation rate due to skin toxicity

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

Progression-free survival

Will be evaluated using the Kaplan-Meier method.

Overall survival

Will be evaluated using the Kaplan-Meier method.

Event-free survival

Will be evaluated using the Kaplan-Meier method.

Full Information

NCT ID

NCT03477110

First Posted

March 19, 2018

Last Updated

June 3, 2021

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

NovoCure Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03477110

Brief Title

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

Official Title

SPARE-Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (NovoTTF, Optune) for Patients With Glioblastoma: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 4, 2018 (Actual)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

NovoCure Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (temozolomide, radiation, NovoTTF-200A device)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

362856, Temcad, Temodal, Methazolastone, Temodar

Intervention Description

Given PO

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Other Intervention Name(s)

Cancer Radiotherapy, Irradiate, RT

Intervention Description

Undergo radiation therapy

Intervention Type

Device

Intervention Name(s)

NovoTTF-200A Device

Other Intervention Name(s)

Optune

Intervention Description

Undergo tumor treatment fields therapy using NovoTTF-200A device

Intervention Type

Procedure

Intervention Name(s)

Tumor Treating Fields Therapy

Other Intervention Name(s)

Alternating Electric Field Therapy

Intervention Description

Undergo tumor treatment fields therapy using NovoTTF-200A device

Primary Outcome Measure Information:

Title

NovoTTF-200A device discontinuation rate due to skin toxicity

Description

Time Frame

Up to 30 days after finishing chemoradiation treatment

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Will be evaluated using the Kaplan-Meier method.

Time Frame

From enrollment up to 1 year

Title

Overall survival

Description

Will be evaluated using the Kaplan-Meier method.

Time Frame

From enrollment up to 1 year

Title

Event-free survival

Description

Will be evaluated using the Kaplan-Meier method.

Time Frame

From enrollment up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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. If the subject can comprehend the informed consent but is unable to sign, a LAR may sign the 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenyin Shi, MD

Phone

215-955-6702

wenyin.shi@jefferson.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wenyin Shi, MD

Organizational Affiliation

Sidney Kimmel Cancer Center at Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sidney Kimmel Cancer Center at Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenyin Shi, MD

Phone

215-955-6702

wenyin.shi@jefferson.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36355259

Citation

Ali AS, Lombardo J, Niazi MZ, Miller RC, Alnahhas I, Martinez NL, Andrews DW, Judy KD, Shi W. Concurrent chemoradiation and Tumor Treating Fields (TTFields, 200 kHz) for patients with newly diagnosed glioblastoma: patterns of progression in a single institution pilot study. J Neurooncol. 2022 Nov;160(2):345-350. doi: 10.1007/s11060-022-04146-w. Epub 2022 Nov 10.

Results Reference

derived

PubMed Identifier

35574391

Citation

Miller R, Song A, Ali A, Niazi M, Bar-Ad V, Martinez N, Glass J, Alnahhas I, Andrews D, Judy K, Evans J, Farrell C, Werner-Wasik M, Chervoneva I, Ly M, Palmer J, Liu H, Shi W. Scalp-Sparing Radiation With Concurrent Temozolomide and Tumor Treating Fields (SPARE) for Patients With Newly Diagnosed Glioblastoma. Front Oncol. 2022 Apr 29;12:896246. doi: 10.3389/fonc.2022.896246. eCollection 2022.

Results Reference

derived

PubMed Identifier

32206976

Citation

Song A, Bar-Ad V, Martinez N, Glass J, Andrews DW, Judy K, Evans JJ, Farrell CJ, Werner-Wasik M, Chervoneva I, Ly M, Palmer JD, Liu H, Shi W. Initial experience with scalp sparing radiation with concurrent temozolomide and tumor treatment fields (SPARE) for patients with newly diagnosed glioblastoma. J Neurooncol. 2020 May;147(3):653-661. doi: 10.1007/s11060-020-03466-z. Epub 2020 Mar 23.

Results Reference

derived

Links:

URL

http://hospitals.jefferson.edu/

Description

Thomas Jefferson University Hospital

Learn more about this trial

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

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