This clinical research study is to learn about the safety of the NovoTTF-200M and Novo TTF-200A Systems, when used either alone or in combination with standard therapy, in patients with tumors that did not respond to treatment.
Patients with one or more spinal metastasis(es) affecting levels between C1 to S4 which have been previously treated with surgery and/or maximal doses radiation therapy to the spinal metastasis. For patients in the surgical group, patients must have completed maximal intralesional debulking of their tumor (within 90 days of enrollment).
No more radiation options available for treatment to the spinal metastasis(es) that will undergo the TTF treatment
Male or Female subjects aged ≥ 22 years.
Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) must agree prior to study entry to use adequate contraception (e.g., hormonal, barrier device, or abstinence) for the duration of study participation.
Psychiatric illness/social situations (homeless or living in a foreign country) that would limit compliance with study requirements.
Physical or cognitive limitation that prevents the ability to independently disconnect the arrays or turn off the system if they feel uncomfortably hot while using the device. This includes patients that need a legally authorized representative for consent.
Patients in the surgery group who have not fully recovered from the spinal surgery, where wound healing is compromised, requiring healing by second intention (i.e., the wound is left open and heals spontaneously).
History of allergic reactions or sensitivity to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
Single group
TTF-200M and TTF-200A systems
DeviceParticipants will receive treatment with NovoTTF-200M or NovoTTF-200A and treatment will continue as long as the doctor thinks it is in the participant's best interest.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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M.D. Anderson Cancer Center
Lead sponsor
NovoCure Ltd.
Collaborator
