HPPH and PDT for Pleural Malignancy

• Status: Completed
• Trial end date: 2014-10-08
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to determine the maximally tolerated photodynamic therapy (PDT) dose and drug-light interval of PDT using light and HPPH in patients with pleural malignancy who have undergone a maximal resection.

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

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania

Criteria

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 < 0.5cm. Patients must have disease limited to the hemithorax. Patients whonhave 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 chemotherapy or radiation therapy after completion of surgery and PDT if these treatments are clinically indicated.

• ECOG performance status of 0-2.

• Medical suitability for resection.

• 18 years 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.

Exclusion Criteria:

• Patients with active co-existing malignancy are excluded.

• Pregnant or lactating patients.

• Patients who have a history of HIV disease.

• Patients who have a white count less than 2500 per cubic mm or platelets less than 100,000/cubic mm.

• Serum creatinine equal or greater than 2.5 mg/deciliter. Patients who have severe liver disease including cirrhosis, Grade III-IV elevations in liver function studies, or bilirubin in excess of 1.5 mg/deciliter.

• Patients with porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.

• Patients who have received prior mantle radiation.

• Patients who have received Alimta<8 weeks prior to surgery.