Spinal Metastasis
Conditions
Brief summary
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.
Detailed description
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 (+/- 1 month) in these patients until one of the following occurs: local disease progression, transition to hospice, loss of follow up, withdrawal from study or consent, whichever comes first. Exploratory Objectives: 1. To evaluate the safety of application of tumor treating fields at frequencies between 150kHZ and 200 KHZ using the TTF-200M and TTF-200A systems (respectively), alone or in combination with available systemic therapy as adjuvant treatment after surgery for spinal cord decompression in patients with refractory spinal metastasis 2. To assess local spine progression-free survivals at about every 3 months (+/- 1 month) until their local disease progresses, they go to hospice, or are off study, whichever is earlier, in patients in 2.3(a). 3. To evaluate the safety of application of tumor treating fields at frequencies between 150kHZ and 200 KHZ using the TTF-200M and TTF-200A systems (respectively), alone or in combination with available systemic therapy as adjuvant treatment for patients with radiation refractory spinal metastasis who are unable to undergo surgery due to high risk of complications. 4. To assess local spine progression-free survivals at about every 3 months (+/- 1 month) until their local disease progresses, they go to hospice, or are off study, whichever is earlier, in patients in 2.3(c). 5. To evaluate change in plasma ctDNA levels before initiation (baseline) to Cycle 1 and 3.
Interventions
DEVICETTF-200M and TTF-200A systems
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.
Sponsors
M.D. Anderson Cancer Center
NovoCure Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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. 5. Patients must have a Karnofsky Performance Scale (KPS) (Appendix D) score of at least 70%. 6. Patients must have the ability to independently disconnect the arrays or turn off the system if they feel uncomfortably hot while using the device. 7. Patients (and/or legally authorized representative) should be able to fully understand the requirements of the trial, including the need to use the device for at least 18 hours per day, be willing to comply with all trial visits and assessments and be willing and able to sign an Institutional Review Board (IRB) approved written informed consent document (or provide assent where applicable). 8. Patients with the following tumor histologies (numbers in parenthesis represent the frequencies/device patients with these histologies will be treated with): 1. Non-small cell lung cancer (150KHZ, TTF-200M) 2. Chordoma (150KHZ, TTF-200M) 3. Breast adenocarcinoma (150HKZ, TTF-200M) 4. Liver/gastrointestinal malignancy (150 KHZ, TTF-200M) 5. Endocrine origin carcinoma (150KHZ, TTF-200M) 6. Renal cell carcinoma (200KHZ, TTF-200A) 7. Prostate adenocarcinoma (200KHZ, TTF-200A) 8. Sarcoma (200KHZ, TTF-200A) 9. For the non-surgical group only, expected survival of more than 8 months as confirmed by the primary oncologist. 10. For the non-surgical group only, in case of multiple noncontiguous vertebral levels requiring treatment, all sites must be included under the largest length of the antero-posterior set of transducer arrays (25cm). 11. Patients who have previously undergone surgery and already have spinal hardware implanted in the intended area of treatment may be enrolled in the surgical group, regardless of the timing of their original surgery.
Exclusion criteria
Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTClaudio Tatsui, MD
PRINCIPAL_INVESTIGATORClaudio Tatsui, MD
M.D. Anderson Cancer Center
Outcome results
None listed