Lung CancerPhase 2NCT00528775
Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages
A Phase 2 study testing HPPH and endoscopic procedure in people with Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- HPPH and endoscopic procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Biopsy confirmed advanced obstructing endobronchial non-small cell lung cancer
- May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology
- Ineligible for or refused surgical resection
- Local endobronchial recurrence after prior surgical resection, radiotherapy, or chemotherapy allowed
- No evidence of tumor encasement of major pulmonary vessels on CT scan of the chest
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
- WBC ≥ 4,000/mm³
- Platelet count ≥ 100,000/mm³
- Prothrombin time < 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 2.0 mg/dL
- Alkaline phosphatase (hepatic) ≤ 3 times ULN
- SGOT ≤ 3 times ULN
- No contraindications for bronchoscopy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after the completion of study treatment
- Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous/debris formation at the site of treatment
- Patients who cannot breathe due to complete upper airway obstruction and who need emergency treatment to open the airway are not eligible
- No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- No severe chronic obstructive pulmonary disease that, in the opinion of the investigator, would preclude multiple bronchoscopies
- No partial central airway obstruction from mucous/debris formation
- No high-grade upper airway obstruction of the trachea
PRIOR CONCURRENT THERAPY:
- Any type of prior therapy (e.g., chemotherapy or radiotherapy) for lung cancer allowed
- At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: A Phase II Study of Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Advanced Obstructing Endobronchial Lung Cancer
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages.
PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.
Read the detailed description
OBJECTIVES:
Primary
- To determine the efficacy of photodynamic therapy (PDT) using HPPH in patients with advanced obstructing endobronchial non-small cell lung cancer.
Secondary
- To determine palliation of symptoms in patients treated with this regimen.
- To determine the amount of HPPH taken up by the obstructing endobronchial tumors in these patients.
- To determine the extent of STAT3 cross-links, which are molecular markers of immediate PDT reaction, in the obstructing tumors of these patients before and after PDT treatment.
- To determine inflammation and apoptosis in the obstructing bronchial tumors of these patients before and after PDT treatment.
OUTLINE: Patients receive HPPH IV over 1 hour on day 1. On day 3, patients undergo photodynamic therapy (PDT) comprising laser light delivered by flexible, fiberoptic fibers passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH.
Patients may undergo tumor biopsies periodically during study for optional biomarker/correlative studies. Tumor tissue samples are analyzed for STAT3 cross-links by western blotting; apoptosis and inflammation biomarkers by immunohistochemistry, TUNEL, and other immunological laboratory methods; and tumor concentrations of HPPH by fluorescence emission spectroscopy.
After completion of study treatment, patients are followed at 4-6 weeks and then periodically thereafter.
- Conditions
- Lung Cancer
- Being tested
- HPPH, endoscopic procedure
- Keywords
- adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPPHDrug
4 mg/m2 IV
endoscopic procedureProcedure or surgery
Treatment with 150 joules from laser
| Study group | Role | What they receive |
|---|---|---|
| HPPH | Experimental | Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light. Receives: Drug: HPPH; Procedure: endoscopic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response
Measured: 6 months
Secondary outcomes (4)
Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale
Measured: 2 months
Photosensitizer (HPPH) Concentration in Tumor
Measured: 2 months
STAT3 Cross-links as Assessed by Western Blotting
Measured: 2 months
Inflammation and Apoptosis as Assessed by Immunohistochemistry
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2009
- Study completionMar 2014
Why it stopped: drug cannot be prepared commercially
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.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Todd L. Demmy, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528775
- Sponsor's protocol ID
- CDR0000563948
- Other IDs
- RPCI-I-98707
- Status last verified
- May 2014
- First submitted
- 10 Sep 2007
- Last updated
- 10 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Advanced Obstructing Endobronchial Lung Cancer
- ClinicalTrials.gov ID
- NCT00528775
- Acronym / sponsor ID
- CDR0000563948
- Conditions
- Lung Cancer
- Keywords
- adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: drug cannot be prepared commercially
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Sep 2007 (estimated)
- Results
- Posted 10 Jun 2014
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 HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages.
PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.
Detailed description
OBJECTIVES:
Primary
- To determine the efficacy of photodynamic therapy (PDT) using HPPH in patients with advanced obstructing endobronchial non-small cell lung cancer.
Secondary
- To determine palliation of symptoms in patients treated with this regimen.
- To determine the amount of HPPH taken up by the obstructing endobronchial tumors in these patients.
- To determine the extent of STAT3 cross-links, which are molecular markers of immediate PDT reaction, in the obstructing tumors of these patients before and after PDT treatment.
- To determine inflammation and apoptosis in the obstructing bronchial tumors of these patients before and after PDT treatment.
OUTLINE: Patients receive HPPH IV over 1 hour on day 1. On day 3, patients undergo photodynamic therapy (PDT) comprising laser light delivered by flexible, fiberoptic fibers passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH.
Patients may undergo tumor biopsies periodically during study for optional biomarker/correlative studies. Tumor tissue samples are analyzed for STAT3 cross-links by western blotting; apoptosis and inflammation biomarkers by immunohistochemistry, TUNEL, and other immunological laboratory methods; and tumor concentrations of HPPH by fluorescence emission spectroscopy.
After completion of study treatment, patients are followed at 4-6 weeks and then periodically thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPPH | Experimental | Drug: HPPH, Procedure: endoscopic procedurePatients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light. |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| HPPH4 mg/m2 IV | Drug | HPPH |
| endoscopic procedureTreatment with 150 joules from laser | Procedure or surgery | HPPH |
Primary outcome
Tumor Response
Time frame: 6 months
4 secondary outcomes
Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale
Time frame: 2 months
Photosensitizer (HPPH) Concentration in Tumor
Time frame: 2 months
STAT3 Cross-links as Assessed by Western Blotting
Time frame: 2 months
Inflammation and Apoptosis as Assessed by Immunohistochemistry
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Todd L. Demmy, MD principal investigator
Roswell Park Cancer Institute
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 HPPH and endoscopic procedure in people with Lung Cancer, run by Roswell Park Cancer Institute 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 10 Jun 2014. 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 10 Jun 2014). 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?
Tumor Response (time frame: 6 months). 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 10 Jun 2014.