Phase I Trial of Photodynamic Therapy with HPPH in Patients with Pleural Malignancy
Title Phase I Trial of Photodynamic Therapy with HPPH in Patients with Pleural Malignancy
Contact MICOOP
Principal Investigator Saikrishna Yendamuri, MD
Study Number 151109
Phase1
Summary This is a Phase I trial of photodynamic therapy for the treatment of patients with pleural malignancies. Patients with resectable pleural tumors will be given the photosensitizer HPPH prior to surgery. After successful tumor removal to a thickness less than or equal to 0.5 cm, 661 nm light from a tunable dye laser or diode laser will be administered. Two parameters will be escalated in this phase I trial, drug-light interval, and light dose. The starting dose of PDT will be 4 mg/m2of HPPH administered 48 hours prior to surgical resection with an initial light dose of 15J/cm2. 661 nm red light will be used to illuminate the entire thoracic cavity. If adequate debulking cannot be performed, the patient will not be eligible to receive light therapy. In parallel laboratory studies, biopsies of tumor and normal tissues will be taken from the resection specimens. Uptake of HPPA will be measured in tumor and normal tissues and tumor to normal tissue ratios of HPPH will be determined. Assessment of molecular signaling including EGFR, Akt and MAPK will be made in tumor prior to and after light delivery when possible. Finally, non-invasive measurements of optical properties, tissue oxygenation, photosensitizer uptake and blood flow will be made intra-operatively when possible.
Eligibility
Inclusion Criteria:
- Patients with a histologic diagnosis of a pleural malignancy who in the opinion of the attending thoracic surgeon can be resected to a maximal thickness of < 0.5 cm. Patients must have disease limited to the hemithorax. Patients who have received prior surgery, gene therapy, or combination chemotherapy will be permitted if it has been at least 30 days since the last treatment. Patients may receive post-operative chemo or radiation therapy after completion of surgery and PDT if these treatments are clinically indicated.
- ECOG performance status of 0-2
- Medically suitability for resection
- 18 yrs of age or older.
- Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling to sign informed consent are excluded from the study
- All cell types of pleural malignancy will be included.
