Photodynamic Therapy for the Treatment of Vertebral Metastases

NCT02464761 | Completed Phase 1 DMC

• 1 other identifier: PDT01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

An estimated 10 percent of primary breast, prostate, lung, thyroid and renal cell tumors metastasize to the spine. The majority of these tumors are detected before surgical intervention is required and most patients receive radiation therapy for symptomatic relief. Complete pain control, duration of pain control, high recurrence rates and soft tissue complications make radiation a less than ideal treatment. Also, pre-operative radiation therapy is a significant negative predictor for surgical outcomes. To improve the treatment options for patients with advanced cancer with spinal lesions the research team investigated a new minimally invasive therapy known as photodynamic therapy (PDT) that targets metastatic spine lesions with limited side effects. PDT involves the use of a photo-activated chemotherapeutic agent, given intravenously that when stimulated by non-thermal wavelength-specific light allows for selective ablation of tumor tissue. The light is delivered to the spine through small fiber optic cables using a diode laser. By combining canine and porcine studies the investigators have strong evidence to support that PDT is both safe and effective for the treatment of metastatic tumors in the spine. PDT is targeted, repeatable, minimally invasive and has limited local and systemic side effects. Its use would enhance the treatment options for patients with advanced stage cancer. The goal of the present study is to demonstrate that PDT can be safely and effectively given to treat spinal metastases in patients with advanced stage cancer who have multiple lesions or who have failed radiation or surgical intervention. The effectiveness of this treatment will be determined through clinical and radiographic endpoints along with recurrence and survival. The investigators intend to demonstrate that PDT is a minimally invasive method with low morbidity and mortality by which spinal tumors can be ablated and later stabilized through vertebroplasty, optimizing quality of life and providing effective treatment.

Conditions

Vertebral Metastases

Outcome Measures

Primary Outcomes (1)

• Intraoperative dosimetry

  Intraoperative dosimetry data on light transmission and attenuation in patient specific diseased bone will be contrasted to pre-operative imaging data and the region of effect based on actual light transmission compared to pre-operative planning algorithms. These results will gauge the potential accuracy of our planning algorithms.

  During surgery

Secondary Outcomes (1)

• Neurologic function

  7 days, 6 weeks

Other Outcomes (2)

• Effect of PDT and vertebral osteoplasty on patient functional outcome - SF36

  7 days, 6 weeks

• Effect of PDT and vertebral osteoplasty on patient functional outcome - VAS scale

  7 days, 6 weeks

Study Arms (1)

Dose escalating PDT

EXPERIMENTAL

Drug: Visudyne

Interventions

Visudyne DRUG

Also known as: Verteporfin

Dose escalating PDT

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 and 85
• Established metastatic vertebral bony disease in the spine
• Eligible for single level vertebral osteoplasty (i.e. percutaneous vertebroplasty, kyphoplasty)
• Patients who are symptomatic with axial pain from vertebral metastatic involvement and are at risk for pathologic fracture; or have had a symptomatic pathologic fracture
• Patients who have shown radiographic progression and/or pain symptoms of a documented vertebral metastasis despite non-surgical therapies

You may not qualify if:

• Progressive neurological compromise
• Osteoblastic vertebral metastatic disease
• Posterior vertebral cortical/body wall involvement
• Spinal canal compromise / neurologic compression
• Anticipated life expectancy of less than twelve weeks to live
• Cognitive impairment and/or language barriers to study participation
• Severe hepatic impairment (Child's C) with active hepatitis or hepatic disease.
• Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. CNS metastases must be stable for \> 2 weeks prior to screening.)
• Nursing mothers, pregnant, currently breastfeeding or trying to get pregnant.
• Unable to avoid sun exposure for 5 day post-PDT therapy (per verteporfin precautions).
• Hyperphotosensitivity conditions, including porphyria
• Hypersensitivity to verteporfin or any other ingredients of Visudyne

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Interventions

Verteporfin

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 8, 2015
• Study Start: June 1, 2011
• Primary Completion: September 7, 2017
• Study Completion: September 7, 2017
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)