NCT06906900

A Phase I Study of the NovoTTF-200M and Novo TTF-200A Systems for the Treatment of Refractory Spinal Metastasis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Metastasis

Interventions

Type	Name	Description
DEVICE	TTF-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.

Timeline

• Start date: 2025-08-18
• Primary completion: 2027-02-17
• Completion: 2029-02-17
• First posted: 2025-04-02
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study