Lung CancerPhase 2NCT00601848
Photodynamic Therapy in Treating Patients With Resectable Non-Small Cell Lung Cancer That Has Spread to the Pleura
A Phase 2 study testing chemotherapy, porfimer sodium and immunohistochemistry staining method in people with Lung Cancer and Metastatic Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells that remain after surgery. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer, Metastatic Cancer
- What is being tested?
- chemotherapy, porfimer sodium and immunohistochemistry staining method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Must have clinical and/or pathological evidence of pleural spread
- Primary tumor must be resectable as assessed by the attending thoracic surgeon
- Patients who have received or are currently receiving two-to-four courses of standard front-line chemotherapy are eligible
PATIENT CHARACTERISTICS:
- Must be medically fit to tolerate surgery
- No CTCAE v3.0 grade III-IV elevations in liver transaminases
- Bilirubin ≤ 1.5 mg/dL
- No known HIV infection
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment for NSCLC except pleurodesis or standard front-line chemotherapy
- No prior pemetrexed disodium chemotherapy
- No prior mantle radiotherapy
- No concurrent chemotherapy or radiotherapy during the active study treatment period
- Post-operative radiotherapy will be administered as clinically indicated
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-small Cell Lung Cancer and Pleural Spread
RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy given during surgery works in treating patients with resectable non-small cell lung cancer that has spread to the pleura.
Read the detailed description
OBJECTIVES:
Primary
- To determine the overall survival rate of patients with non-small cell lung cancer (NSCLC) and malignant pleural spread treated with standard front-line chemotherapy followed by surgical resection and intra-operative porfimer sodium (Photofrin®)-mediated photodynamic therapy.
- To determine the feasibility and toxicities of standard front-line chemotherapy followed by surgical resection and intra-operative Photofrin®-mediated photodynamic therapy in these patients.
Secondary
- To determine the progression-free survival and pleural progression-free survival of these patients.
- To determine the absolute Photofrin® levels in tumor and normal tissues resected from these patients using spectrofluorometric methods.
- To determine the tumor to normal tissue ratios of Photofrin® in these patients.
- To measure the optical properties of tumor and normal tissues in situ.
- To compare the Photofrin® concentration of tumor and normal tissues made with the in situ measurements to the measurements made with spectrofluorometric method.
OUTLINE: This is a multicenter study.
Patients receive 2-4 courses of standard front-line chemotherapy prior to surgery (if they have not completed the front-line chemotherapy).
Patients receive porfimer sodium (Photofrin®) IV over 5-15 minutes. Approximately 24 hours after receiving porfimer sodium, patients undergo surgery to remove the primary tumor and the pleural disease to a thickness of 5 mm or less*. Patients then undergo intraoperative photodynamic therapy to the residual disease. Some patients may undergo postoperative radiotherapy to the mediastinum and/or surgical scar if clinically indicated.
NOTE: *If the disease cannot be resected to less than 5 mm, PDT will not be delivered
Tumor and normal tissue samples are obtained from the surgical specimen and examined prior to light delivery at the time of thoracotomy, and after light delivery. Tissue samples are analyzed for porphyrin levels using a spectrofluorometric assay of tissue specimens and an in situ optical method intra-operatively. Samples are also assessed for V-cadherin, markers for oxidative stress, markers associated with photosensitizer uptake, markers for angiogenesis, markers for hypoxia, activation of signaling pathway components (including EGFR, p38 MAPK, Akt, and p42/44 MAPK) via immunohistochemistry.
After completion of study treatment, patients are followed periodically for 2 years.
- Conditions
- Lung Cancer, Metastatic Cancer
- Being tested
- chemotherapy, porfimer sodium, immunohistochemistry staining method, laboratory biomarker analysis, spectroscopy
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, malignant pleural effusion
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
porfimer sodiumDrug
laboratory biomarker analysisOther
spectroscopyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic Therapy | Experimental | PDT Receives: Drug: chemotherapy; Drug: porfimer sodium; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: spectroscopy; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity Assessment of Pleural Photodynamic Therapy
Toxicities of PDT as defined by CTCAE v4.0
Measured: One year
Overall Survival
Subject survival post PDT
Measured: 5 years
Pleural Progression-free Survival
Amount of time from PDT to disease progression in pleura
Measured: 5 years
Secondary outcomes (2)
Progression-free Survival
Amount of time from PDT to disease progression at any site in the body
Measured: 5 years
Photofrin® Uptake
Measured uptake of PDT drug
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startNov 2004
- Primary completionFeb 2012
- Study completionDec 2012
Why it stopped: Poor accrual and change in standards of care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Keith Cengel, MD, PhD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601848
- Sponsor's protocol ID
- UPCC 05503
- Other IDs
- CDR0000583050
- Status last verified
- Apr 2020
- First submitted
- 25 Jan 2008
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-small Cell Lung Cancer and Pleural Spread
- ClinicalTrials.gov ID
- NCT00601848
- Acronym / sponsor ID
- UPCC 05503
- Conditions
- Lung Cancer, Metastatic Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, malignant pleural effusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual and change in standards of care
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2004
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy given during surgery works in treating patients with resectable non-small cell lung cancer that has spread to the pleura.
Detailed description
OBJECTIVES:
Primary
- To determine the overall survival rate of patients with non-small cell lung cancer (NSCLC) and malignant pleural spread treated with standard front-line chemotherapy followed by surgical resection and intra-operative porfimer sodium (Photofrin®)-mediated photodynamic therapy.
- To determine the feasibility and toxicities of standard front-line chemotherapy followed by surgical resection and intra-operative Photofrin®-mediated photodynamic therapy in these patients.
Secondary
- To determine the progression-free survival and pleural progression-free survival of these patients.
- To determine the absolute Photofrin® levels in tumor and normal tissues resected from these patients using spectrofluorometric methods.
- To determine the tumor to normal tissue ratios of Photofrin® in these patients.
- To measure the optical properties of tumor and normal tissues in situ.
- To compare the Photofrin® concentration of tumor and normal tissues made with the in situ measurements to the measurements made with spectrofluorometric method.
OUTLINE: This is a multicenter study.
Patients receive 2-4 courses of standard front-line chemotherapy prior to surgery (if they have not completed the front-line chemotherapy).
Patients receive porfimer sodium (Photofrin®) IV over 5-15 minutes. Approximately 24 hours after receiving porfimer sodium, patients undergo surgery to remove the primary tumor and the pleural disease to a thickness of 5 mm or less*. Patients then undergo intraoperative photodynamic therapy to the residual disease. Some patients may undergo postoperative radiotherapy to the mediastinum and/or surgical scar if clinically indicated.
NOTE: *If the disease cannot be resected to less than 5 mm, PDT will not be delivered
Tumor and normal tissue samples are obtained from the surgical specimen and examined prior to light delivery at the time of thoracotomy, and after light delivery. Tissue samples are analyzed for porphyrin levels using a spectrofluorometric assay of tissue specimens and an in situ optical method intra-operatively. Samples are also assessed for V-cadherin, markers for oxidative stress, markers associated with photosensitizer uptake, markers for angiogenesis, markers for hypoxia, activation of signaling pathway components (including EGFR, p38 MAPK, Akt, and p42/44 MAPK) via immunohistochemistry.
After completion of study treatment, patients are followed periodically for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodynamic Therapy | Experimental | Drug: chemotherapy, Drug: porfimer sodium, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: spectroscopy, Procedure: therapeutic conventional surgeryPDT |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy | Drug | Photodynamic Therapy |
| porfimer sodium | Drug | Photodynamic Therapy |
| immunohistochemistry staining method | Other | Photodynamic Therapy |
| laboratory biomarker analysis | Other | Photodynamic Therapy |
| spectroscopy | Procedure or surgery | Photodynamic Therapy |
| therapeutic conventional surgery | Procedure or surgery | Photodynamic Therapy |
Primary outcome
Toxicity Assessment of Pleural Photodynamic Therapy
Time frame: One year
Toxicities of PDT as defined by CTCAE v4.0
Overall Survival
Time frame: 5 years
Subject survival post PDT
Pleural Progression-free Survival
Time frame: 5 years
Amount of time from PDT to disease progression in pleura
2 secondary outcomes
Progression-free Survival
Time frame: 5 years
Photofrin® Uptake
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Cengel, MD, PhD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy, porfimer sodium and immunohistochemistry staining method in people with Lung Cancer and Metastatic Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity Assessment of Pleural Photodynamic Therapy (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.