Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
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|ClinicalTrials.gov Identifier: NCT03033992|
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma Ependymoma||Device: Optune System (NovoTTF-200A System, Tumor Treating Fields, TTFields)||Not Applicable|
I To establish the feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.
II To describe the Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma.
I To estimate the response rate and Event-Free Survival (EFS) as markers of anti-tumor activity of the Optune device within the context of a feasibility trial.
II To assess the association of anti-tumor activity with compliance in Optune device use within the context of a small feasibility study.
III To explore the impact of the Optune device on the children and families undergoing this therapy, and to explore the association between demographic (e.g., SES, gender), disease (e.g., risk status), treatment, and behavioral variables with health-related quality of life (QoL) changes.
IV To explore the association of apparent diffusion coefficient (ADC) values within the tumor and correlate with response to Optune treatment and EFS.
The Optune will be worn for a minimum of 18 hours a day, with a recommendation of 22 hours/day for at least 23 days in a 28-day cycle. Cycle 1 includes 7 days training period, followed by 28 days treatment (total 35 days). The patients will receive multiple 28-day cycles of continuous Optune treatment. In the absence of treatment related serious adverse events or disease progression, Optune will continue up to 26 cycles.
The patients will be followed up for 30 days after the last application of the Optune device.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Treatment (Optune System)
Patients must have a histologically confirmed diagnosis of supratentorial high-grade glioma or supratentorial ependymoma that is recurrent, progressive or refractory. All patients will use the study device Optune System (Tumor Treating Fields, TTFields).
Device: Optune System (NovoTTF-200A System, Tumor Treating Fields, TTFields)
The Optune, a.k.a. Tumor Treating Fields (TTFields), will be worn for a minimum of 18 hours a day, with a recommendation of 22 hours/day for at least 23 days in a 28-day cycle. Cycle 1 includes 7 days training period, followed by 28 days treatment (total 35 days). The patients will receive multiple 28-day cycles of continuous Optune treatment. In the absence of treatment related serious adverse events or disease progression, Optune will continue up to 26 cycles.
Other Name: Optune System (NovoTTF-200A System)
- The feasibility of treatment with the Optune device in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. [ Time Frame: days 8 through 35 of cycle 1 ]Device Usage Compliance will be reported to assess the feasibility of the device treatment.
- The Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. [ Time Frame: 2 years ]Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
- The Response Rate [ Time Frame: 2 years ]The response rate is calculated according to the bi-dimensional tumor measurement at the end of treatment compared with the baseline measurements.
- The Event-Free Survival [ Time Frame: 2 years ]The event-free survival is the interval of time between date of initiation of protocol treatment and minimum date of documentation of progressive disease, second malignancy, death due to any cause, or date of last follow-up.
- The association of anti-tumor activity with compliance in Optune device use within the context of a small feasibility study. [ Time Frame: 2 years ]The anti-tumor activity will be classified as complete response, partial response, stable disease, and progressive disease per protocol specified criteria. The compliance in Optune device use will be calculated as the actual hours of Optune device usage per day.
- The association between the Optune device usage and the health-related quality of life of children and families undergoing this therapy. [ Time Frame: 2 years ]The Quality of Life Scores will be reported at baseline, and with each cycle using PROMIS and Neuro-QoL Stigma, in which the mean score of the general population is 50 and standard deviation is 10.
- The association of apparent diffusion coefficient (ADC) values within the tumor and correlate with response to Optune treatment and EFS. [ Time Frame: 2 years ]We will summarize the tumor-type specific ADC value at baseline and at various times on treatment as well as within-patient changes over time. The ADC value of responders will be compared to the ADC value of those with progressive diseases at baseline and over time.
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): NCT03033992
|Contact: Shujie Han, Ph.D., CCRA||901-595-4877||Shujie.Han@stjude.org|
|Contact: Stacye Richardson, MSHS, CCRP||901-595-3783||Stacye.Richardson@stjude.org|
|United States, California|
|Children's Hospital Los Angeles||Recruiting|
|Los Angeles, California, United States, 90026|
|Contact: Girish Dhall, MD 323-361-4629 email@example.com|
|Contact: Kelley Haley, BSN,RN,CCRP 323-361-2480 firstname.lastname@example.org|
|Principal Investigator: Girish Dhall, MD|
|Lucile Packard Children's Hospital at Stanford University Medical Center||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Paul G. Fisher, MD, MHS 650-497-8953 email@example.com|
|Contact: Leah White 650-725-4708 firstname.lastname@example.org|
|United States, District of Columbia|
|Children's National Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20010-2970|
|Contact: Roger J. Packer, MD 202-884-2120 email@example.com|
|Contact: Eugene Hwang, MD 202-476-5046 firstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Emily Golbeck 312-227-4858 EGolbeck@luriechildrens.org|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Ira Dunkel, MD 212-639-2153 email@example.com|
|Contact: Ryan Turner 646-888-5723 firstname.lastname@example.org|
|Principal Investigator: Ira Dunkel, MD|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Maryam Fouladi, MD 513-803-0721 email@example.com|
|Contact: CCHMC Cancer Line 513-636-2799 Cancer@cchmc.org|
|United States, Pennsylvania|
|Children Hospital of Pittsburgh of UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15224|
|Contact: Ian Pollack, MD 412-692-5881 Pollaci@chp.edu|
|Contact: Sharon DiBridge 412-692-7070 firstname.lastname@example.org|
|Principal Investigator: Ian Pollack|
|United States, Tennessee|
|Saint Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105-2794|
|Contact: Anna Vinitsky, MD 901-595-3300 email@example.com|
|Contact: Dillon Robinson, MPH 901-595-5922 Dillon.Robinson@stjude.org|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Patricia Baxter, MD 832-824-4681 firstname.lastname@example.org|
|Contact: Susan Burlingame, CCRP 832-824-1532 email@example.com|
|Principal Investigator: Patricia Baxter, MD|
|Principal Investigator:||Stewart Goldman, MD||Ann & Robert H. Lurie Children Hospital of Chicago|