M.D. Anderson Cancer Center
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.
Primary Objective: To evaluate the safety of applying TTFields at frequencies between 150 and 200KHz, using the TTF200M and TTF-200A systems (respectively), alone or in combination with available systemic therapies as adjuvant treatment in patients with radiation refractory spinal metastasis. Safety will be specifically assessed based on absence of wound dehiscence in the surgical group and severe cellulitis requiring drainage and intravenous antibiotics in both surgical and non-surgical cohorts. Secondary Objective: To assess local spine progression-free survivals at about every 3 months (…
Inclusion Criteria: 1. 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). 2. No more radiation options available for treatment to the spinal metastasis(es) that will undergo the TTF treatment 3. Male or Female subjects aged ≥ 22 years. 4. Women of child-bearing potential (women who are not postmenopausal for a…
Participants 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.
Arctuva estimate
Verify or correct the compensation shown for this listing.