Photodynamic Therapy for the Treatment of Vertebral Metastases

• Status: Completed
• Trial end date: 2017-09-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Treatments: Verteporfin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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