Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma (NCT03450850) | Clinical Trial Compass
CompletedNot Applicable
Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma
United States1 participantsStarted 2020-05-21
Plain-language summary
This is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3 astrocytoma) who had progressive disease during first or second line treatment and who have not previously received any BEV or any experimental agents.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Understand and voluntarily sign and date an informed consent document before any study related assessments/procedures are conducted.
. Males and females of age ≥18 years at the time of the signing of the informed consent document.
. All subjects must have histologic evidence of G3 MG and radiographic evidence of recurrence or disease progression (defined as either a greater than 25% increase in the largest bi-dimensional product of enhancement, a new enhancing lesion or a significant increase in T2 FLAIR).
. Subjects with archival tumor tissue suitable for genetic testing must give permission to access and test the tissue; subjects without archival tumor tissue are eligible.
. No prior treatment with BEV or any anti-angiogenesis agents.
. At least 4 weeks from surgical resection and 12 weeks from end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are 8 weeks apart.
. All AEs resulting from prior chemotherapy, surgery or radiotherapy must have resolved to NCI-CTCAE (v. 4.03) Grade ≤1 (except for laboratory parameters outlined below).
. Laboratory results within 7 days prior to NOVOTTF-200A administration (transfusions and/or growth factor support may be used at the discretion of the Investigator during Screening):
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a device called NovoTTF-200A for Grade III malignant astrocytoma — can you explain how tumor treating fields technology works and whether the results from this completed study suggest it could be relevant to my specific situation?
2The trial focused on patients who had not previously received bevacizumab — does my treatment history make me similar to the patients who were enrolled in this study, and does that affect whether its findings might apply to me?
3The main thing this trial measured was how many patients showed no disease progression at six months — what did the results actually show, and how does that compare to what I might expect from standard treatment options for recurrent Grade III astrocytoma?
4Since this trial is listed as phase NA rather than a traditional Phase I, II, or III study, what does that mean for how much is known about the safety and effectiveness of this device, and are there any newer or larger studies I should be aware of?
5This trial involved wearing a device to deliver the treatment — can you help me understand what that would mean for daily life, and whether a device-based approach like this is something worth seriously considering alongside or instead of other options available to me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Showing no Evidence of Disease Progression Six Months After Initiating Treatment With the Device.
. The presence of 1p19q LOH which is diagnostic for anaplastic oligodendroglioma (AO).
. Co-medication that may interfere with study results, e.g., immunosuppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to study beginning.)
. Chemotherapy administered within 4 weeks (6 weeks for an IV nitrosoureas and 12 weeks for an implanted nitrosoureas wafer) prior to Day 1 of study treatment.
. Pregnancy or breastfeeding.
. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics \& psychiatric illness/social situations that would limit adherence with study requirements, or disorders associated with significant immunocompromised state.
. Known previous/current malignancy requiring treatment within ≤ 3 years except for cervical carcinoma in situ, squamous or basal cell skin carcinoma and superficial bladder carcinoma.
. Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator.