HPPH and PDT for Pleural Malignancy

April 7, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Number of Adverse Events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center of the University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keith Cengel, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPCC 02507

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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