Recurrent Non-Small Cell Lung CarcinomaPhase 1NCT01854684
Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery
A Phase 1 study testing Temoporfin, Therapeutic Conventional Surgery and Photodynamic Therapy in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IIA Non-Small Cell Lung Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of photodynamic therapy during surgery in treating patients with non-small cell lung cancer that can be removed by surgery. Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed to a certain kind of light. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma, Stage IIB Non-Small Cell Lung Carcinoma
- What is being tested?
- Temoporfin, Therapeutic Conventional Surgery and Photodynamic Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2014to 4 Sep 2018
- 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
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Patients with resectable primary NSCLC who are undergoing surgery to resect T3 to T4 lesions OR any patients with clinical NI or N2 disease regardless of T-stage
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2
- Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after surgery; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- The subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure
- Must consent to participate in study I 03103: Roswell Park Cancer Institute (RPCI) Data Bank and Biorepository (DBBR)
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients with known brain metastases should be excluded from this clinical trial
- Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
- White blood cell (WBC) < 4,000
- Platelet count < 100,000
- Total serum bilirubin > 2 mg/dL
Show all 13Show fewer
- Serum creatinine > 2 mg/dL
- Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or nursing female subjects
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug
- Received an investigational agent within 30 days prior to enrollment
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 Surgery Plus Intraoperative Photodynamic Therapy (PDT) With Temoporfin in Patients With Resectable Primary Non-small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease
This phase I trial studies the side effects and best dose of photodynamic therapy during surgery in treating patients with non-small cell lung cancer that can be removed by surgery. Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be a better way to treat patients with non-small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To demonstrate that intraoperative adjuvant regional photodynamic therapy with low-dose temoporfin is safe.
SECONDARY OBJECTIVES:
- Initial assessment of efficacy (i.e., 2-year disease free survival). II. To investigate the relationship between signal transducer and activator of transcription 3 (STAT3) levels, measured light dose and the clinical outcome.
III. Correlate the serum concentrations of vitamin D metabolites (25-hydroxyvitarnin D3 and 1,25-dihydroxyvitamin D3) with the presence of lymph node (LN) metastasis at the time of surgical resection.
IV. To measure temoporfin uptake in malignant and normal tissue.
OUTLINE: This is a dose-escalation study of photodynamic therapy with temoporfin.
Patients receive temoporfin intravenously (IV) over no less than 6 minutes and then undergo standard surgical resection with intraoperative photodynamic therapy (PDT).
After completion of study treatment, patients are followed up every 6 months for 2 years.
- Conditions
- Recurrent Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma, Stage IIB Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer
- Being tested
- Temoporfin, Therapeutic Conventional Surgery, Photodynamic Therapy, Laboratory Biomarker Analysis, Pharmacological Study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemoporfinDrug
Also called Foscan, mTHPC
Given IV
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgical resection
Photodynamic TherapyDrug
Also called Light Infusion Therapy™, PDT, Photoradiation Therapy
Undergo intraoperative PDT
Laboratory Biomarker AnalysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (surgery and intraoperative PDT) | Experimental | Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT. Receives: Drug: Temoporfin; Procedure: Therapeutic Conventional Surgery; Drug: Photodynamic Therapy; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of PDT with temoporfin, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: 2 weeks
Secondary outcomes (4)
Locoregional recurrence-free rate
Estimated using simple relative frequencies. The corresponding 95% confidence interval for the estimated probability will be computed using the method proposed by Clopper and Pearson. Maximum likelihood estimation will be utilized in the model fitting procedures.
Measured: Up to 2 years
Overall survival
Distribution will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
Measured: Up to 2 years
Progression free survival
Distribution will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
Measured: Up to 2 years
Toxicity rate, using NCI CTCAE version 4
Estimated using simple relative frequencies. The corresponding 95% confidence interval for the estimated probability will be computed using the method proposed by Clopper and Pearson. Maximum likelihood estimation will be utilized in the model fitting procedures.
Measured: Up to 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study start21 Feb 2014
- Primary completion4 Sep 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Non-Small Cell Lung CarcinomaStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chukwumere Nwogu, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854684
- Sponsor's protocol ID
- I 228112
- Other IDs
- NCI-2013-00886, I 228112
- Status last verified
- Jul 2022
- First submitted
- 13 May 2013
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) With Temoporfin in Patients With Resectable Primary Non-small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease
- ClinicalTrials.gov ID
- NCT01854684
- Acronym / sponsor ID
- I 228112
- Conditions
- Recurrent Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma, Stage IIB Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 21 Feb 2014 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 15 May 2013 (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 studies the side effects and best dose of photodynamic therapy during surgery in treating patients with non-small cell lung cancer that can be removed by surgery. Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be a better way to treat patients with non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES:
- To demonstrate that intraoperative adjuvant regional photodynamic therapy with low-dose temoporfin is safe.
SECONDARY OBJECTIVES:
- Initial assessment of efficacy (i.e., 2-year disease free survival). II. To investigate the relationship between signal transducer and activator of transcription 3 (STAT3) levels, measured light dose and the clinical outcome.
III. Correlate the serum concentrations of vitamin D metabolites (25-hydroxyvitarnin D3 and 1,25-dihydroxyvitamin D3) with the presence of lymph node (LN) metastasis at the time of surgical resection.
IV. To measure temoporfin uptake in malignant and normal tissue.
OUTLINE: This is a dose-escalation study of photodynamic therapy with temoporfin.
Patients receive temoporfin intravenously (IV) over no less than 6 minutes and then undergo standard surgical resection with intraoperative photodynamic therapy (PDT).
After completion of study treatment, patients are followed up every 6 months 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 |
|---|---|---|
| Treatment (surgery and intraoperative PDT) | Experimental | Drug: Temoporfin, Procedure: Therapeutic Conventional Surgery, Drug: Photodynamic Therapy, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyPatients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Patients with resectable primary NSCLC who are undergoing surgery to resect T3 to T4 lesions OR any patients with clinical NI or N2 disease regardless of T-stage
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2
- Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after surgery; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- The subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure
Key exclusion criteria (13 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients with known brain metastases should be excluded from this clinical trial
- Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
- White blood cell (WBC) < 4,000
- Platelet count < 100,000
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 |
|---|---|---|
| TemoporfinAlso: Foscan, mTHPCGiven IV | Drug | Treatment (surgery and intraoperative PDT) |
| Therapeutic Conventional SurgeryUndergo surgical resection | Procedure or surgery | Treatment (surgery and intraoperative PDT) |
| Photodynamic TherapyAlso: Light Infusion Therapy™, PDT, Photoradiation TherapyUndergo intraoperative PDT | Drug | Treatment (surgery and intraoperative PDT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (surgery and intraoperative PDT) |
| Pharmacological StudyAlso: pharmacological studiesCorrelative studies | Other | Treatment (surgery and intraoperative PDT) |
Primary outcome
Maximum tolerated dose of PDT with temoporfin, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time frame: 2 weeks
4 secondary outcomes
Locoregional recurrence-free rate
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Progression free survival
Time frame: Up to 2 years
Toxicity rate, using NCI CTCAE version 4
Time frame: Up to 30 days after completion of study treatment
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 22 Jul 2022.
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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.
Chukwumere Nwogu 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 Temoporfin, Therapeutic Conventional Surgery and Photodynamic Therapy in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IIA Non-Small Cell Lung Carcinoma, 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 6 inclusion and 13 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 22 Jul 2022. 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?
Maximum tolerated dose of PDT with temoporfin, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 (time frame: 2 weeks). 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 22 Jul 2022.