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A Phase 1 Trial of Photodynamic Therapy With HPPH in Patients With Pleural Malignancy

Phase 1
18 Years
Open (Enrolling)
Pleural Malignancy

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Trial Information

A Phase 1 Trial of Photodynamic Therapy With HPPH in Patients With Pleural Malignancy

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.

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.

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Safety Issue:


Principal Investigator

Keith Cengel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Food and Drug Administration

Study ID:

UPCC 02507



Start Date:

November 2007

Completion Date:

December 2013

Related Keywords:

  • Pleural Malignancy
  • Neoplasms



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283