Adenocarcinoma of the LungPhase 1NCT01668823
Photodynamic Therapy in Treating Patients With Lung Cancer
A Phase 1 study testing HPPH, photodynamic therapy and therapeutic bronchoscopy in people with Adenocarcinoma of the Lung and Large Cell Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with lung cancer. 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, cancer cells are killed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer
- What is being tested?
- HPPH, photodynamic therapy and therapeutic bronchoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer
- Patients may have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma
- Patients may have received prior therapy for lung cancer of any type, e.g. chemotherapy, radiation therapy
- Patients must have no contraindications for bronchoscopy
- Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
- Patients must have a Karnofsky scale 50 or above (Eastern Cooperative Oncology Group [ECOG] 0-2)
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- Patients must sign an Informed Consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
- Patients with underlying lung disease must be judged (by the principal investigator) able to with stand mucous/debris formation at the site of treatment
- Definition of CIS or microinvasive lung cancer for this protocol: the lesion will be radiographically occult and not definable by conventional computed tomography (CT) of the chest; the lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on lung imaging fluorescence endoscope (LIFE) bronchoscopy; biopsies of the lesion must indicate no evidence of invasion beyond cartilage on histopathology; the lesion may, however, be invasive through the basement membrane (microinvasive carcinoma)
Who cannot join
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- White blood cells (WBC) < 4000
- Platelet count < 100,000
- Prothrombin time exceeding 1.5 times the upper normal limit
- Total serum bilirubin > 3.0 mg/dl
- Serum creatinine > 3.0 mg/dl
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- Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
- Severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation
- Any evidence of worsening pulmonary symptoms or COPD exacerbation
- Evidence of major pulmonary vessel encasement on CT scan of the chest
- Myocardial infarction (Ml) or unstable angina in the previous 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study
This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with lung cancer. 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, cancer cells are killed.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue toxicity using 2-[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma.
SECONDARY OBJECTIVES:
- To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or bronchogenic microinvasive carcinoma.
OUTLINE: This is a dose-escalation study.
Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and then periodically for at least 2 years.
- Conditions
- Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage 0 Non-small Cell Lung Cancer
- Being tested
- HPPH, photodynamic therapy, therapeutic bronchoscopy
- Medical subject headings
- 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
Also called Photochlor
Given IV
photodynamic therapyDrug
Also called Light Infusion Therapy™, PDT, therapy, photodynamic
Undergo photodynamic therapy with HPPH
therapeutic bronchoscopyProcedure or surgery
Undergo therapeutic bronchoscopy for endoscopic debridement
| Study group | Role | What they receive |
|---|---|---|
| Treatment (PDT using HPPH) | Experimental | Patients receive HPPH IV over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5. Receives: Drug: HPPH; Drug: photodynamic therapy; Procedure: therapeutic bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTID
Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.
Measured: Up to 2 years
Systemic toxicity according to NCI Common Toxicity Criteria version 2
Measured: Up to 6 months
PDT-related normal tissue toxicity
Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.
Measured: Up to 6 months
Secondary outcomes (1)
Objective tumor response
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startFeb 2004
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the LungStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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
- Samjot Dhillon, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668823
- Sponsor's protocol ID
- I 05903
- Other IDs
- NCI-2010-02114
- Status last verified
- Jul 2014
- First submitted
- 16 Aug 2012
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study
- ClinicalTrials.gov ID
- NCT01668823
- Acronym / sponsor ID
- I 05903
- Conditions
- Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage 0 Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2004
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with lung cancer. 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, cancer cells are killed.
Detailed description
PRIMARY OBJECTIVES:
- To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue toxicity using 2-[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma.
SECONDARY OBJECTIVES:
- To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or bronchogenic microinvasive carcinoma.
OUTLINE: This is a dose-escalation study.
Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and then periodically for at least 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 |
|---|---|---|
| Treatment (PDT using HPPH) | Experimental | Drug: HPPH, Drug: photodynamic therapy, Procedure: therapeutic bronchoscopyPatients receive HPPH IV over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer
- Patients may have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma
- Patients may have received prior therapy for lung cancer of any type, e.g. chemotherapy, radiation therapy
- Patients must have no contraindications for bronchoscopy
- Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
Key exclusion criteria (11 listed)
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- White blood cells (WBC) < 4000
- Platelet count < 100,000
- Prothrombin time exceeding 1.5 times the upper normal limit
- Total serum bilirubin > 3.0 mg/dl
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 |
|---|---|---|
| HPPHAlso: PhotochlorGiven IV | Drug | Treatment (PDT using HPPH) |
| photodynamic therapyAlso: Light Infusion Therapy™, PDT, therapy, photodynamicUndergo photodynamic therapy with HPPH | Drug | Treatment (PDT using HPPH) |
| therapeutic bronchoscopyUndergo therapeutic bronchoscopy for endoscopic debridement | Procedure or surgery | Treatment (PDT using HPPH) |
Primary outcome
MTID
Time frame: Up to 2 years
Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.
Systemic toxicity according to NCI Common Toxicity Criteria version 2
Time frame: Up to 6 months
PDT-related normal tissue toxicity
Time frame: Up to 6 months
Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.
1 secondary outcome
Objective tumor response
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
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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.
Samjot Dhillon 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 1 study testing HPPH, photodynamic therapy and therapeutic bronchoscopy in people with Adenocarcinoma of the Lung and Large Cell 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?
The sponsor lists 9 inclusion and 11 exclusion criteria. 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: finished, as of the sponsor's last update on 31 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MTID (time frame: Up to 2 years). 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 31 Jul 2014.