Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors

Inclusion Criteria

• •Target tumors accessible for percutaneous implantation under CT (and ultrasound if needed) guidance in any superficial location, sarcoma, tumors of oral/oro-pharyngeal cavity, tumors with extensive pelvic involvement, or liver metastasis.
• •Patient has failed prior surgery or chemotherapy or radiation therapy and the tumor is refractory.
• •Tumor mass is not immediately adjacent to, or directly invading a major vessel or hollow viscus such that tumor necrosis could result in hemorrhage or perforation.
• •Patient has not received prior chemotherapy for at least 4 weeks and patient has recovered from toxicity.
• •Patient has an ECOG performance status of 0-3 (Karnofsky 30 or higher).
• •If patients have received radiotherapy to sites of disease other than the one planned for insertion of the light delivery catheter, then the patient must have no current local or systemic toxicity from the prior radiation.
• •Patient has recovered from all previous surgery in the judgment of the Principal Investigator.
• •Patient has not been treated with any biologics (excluding hormones) at least 4 weeks prior to the screening and patient has recovered from any toxicity.
• •Age 18 or older.
• •Minimum life expectancy of 12 weeks.
• •Ability to provide informed consent.
• •All tumors must:
• •* have a minimum dimension that exceeds 4 x 2.8 cm;
• •* have a shape and location such that the mid-point on the light delivery catheter will be greater than 2.0 cm from any structure which, if damaged by PDT treatment, would result in pain or injury to the patient.