HPPH and PDT for Pleural Malignancy

NCT01673074 | Completed Phase 1 DMC

• 1 other identifier: UPCC 02507
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pleural Malignancy

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

Interventions

(PDT) Photodynamic therapy DRUG

photosensitizer

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Ultraviolet Therapy

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Keith Cengel, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 27, 2012
• Study Start: November 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: October 8, 2014
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

US (1)