HPPH and PDT for Pleural Malignancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01673074
First received: August 20, 2012
Last updated: October 10, 2014
Last verified: October 2014

August 20, 2012
October 10, 2014
November 2007
December 2013   (final data collection date for primary outcome measure)
Number of Adverse Events [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01673074 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
HPPH and PDT for Pleural Malignancy
A Phase 1 Trial of Photodynamic Therapy With HPPH in Patients With Pleural Malignancy

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.

Photodynamic therapy (PDT) is an experimental treatment that uses a drug called a photosensitizer or photosensitizing agent and light to kill cells. When photosensitizers are exposed to a specific wavelength of light, they produce a form of oxygen that kills hearby cells. The appeal o PDT in oncology has been that the photosensitizer is retained in tumor tissue for longer periods of time compared to normal tissues. This reported differential of photosensitizer retention in tumor compared to normal tissues provides the potential for an enhanced therapeutic index minimizing normal tissue toxicity has prompted an interest in studying PDT as a cancer treatment and is a proposed treatment for a variety of malignancies and pre-malignant conditions. The proposed study is a Phase I trial of photodynamic therapy (PDT) for the treatment of patients with pleural malignancies. To participate patients must be 18 years of age or older, must have a histological diagnosis of pleural malignancy, must have disease limited to the hemithorax (one side of the chest), must be medically suitable for resection, and must have a ECOG performance status of 0-2. Patients who have received prior surgery, gene therapy, or combination chemotherapy will also be permitted if it has been at least 30 days since the last treatment. Patients will be given HPPH, by intravenous injection prior to surgery. HPPH is a chlorine based photosensitizer used along with PDT to prevent recurrence of tumors following surgical removal. After successful tumor removal light from a tunable dye laser or diode laser will be administered. The starting dose of PDT will ve administered 24 or 48 hours prior to surgical resection. Red light will be used to illuminate the entire thoracic cavity. If adequate removal of the tumor 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 HPPH 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. Patients will simultaneously be enrolled on a companion protocol in which the 2-nitroimidazole, EF5 will be administered to determine tumor oxygen concentration. Finally, non-invasive measurements of optical properties, tissue oxygenation, photosensitizer uptake, and blood flow will be made intraoperatively. After hospital discharge patients will be seen routinely in outpatient Thoracic Surgery and Radiation Oncology Department clinics. These follow visits will occur one month., two months later and every three months of the first 24 months to assess treatment related toxicities. A history and physical examination, laboratory and a CT or MRI of the chest will be performed every 3 months. A follow-up chest x-ray will be obtained as clinically indicated. An assessment of toxicity will be made at each follow-up visit. After 24 months, follow-up should be scheduled as clinically indicated.

Interventional
Phase 1
Primary Purpose: Treatment
Pleural Malignancy
Drug: (PDT) Photodynamic therapy
photosensitizer
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01673074
UPCC 02507
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Principal Investigator: Keith Cengel, MD Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP