Recurrent Laryngeal Squamous Cell CarcinomaPhase 2NCT02068157
Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
A Phase 2 study testing Laboratory Biomarker Analysis, Photodynamic Therapy and Porfimer Sodium in people with Recurrent Laryngeal Squamous Cell Carcinoma and Recurrent Laryngeal Verrucous Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis, Photodynamic Therapy and Porfimer Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2014to 4 Nov 2016
- 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
Who may be able to join
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Histologically confirmed recurrent squamous cell carcinoma of the oral cavity, pharynx, (oropharynx, larynx) and neck
- Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
- Patients on chemotherapy \&/or targeted agents for palliation
- Life expectancy of at least 6 months in the judgment of the physician
- 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 the last treatment; 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
- Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Radiotherapy within the last 2 months in the area to be treated
- Patients with known brain metastases should be excluded from this clinical trial
- Tumor invading a major blood vessel (such as the carotid artery)
- Tumor is not clearly shown on a computed tomography (CT) scan
- Location and extension of the tumor precludes an effective I-PDT
- Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
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- While blood cell (WBC) < 2.0 x 10^9/L
- Total serum bilirubin > 2.0 mg/dl
- Serum creatinine > 2 mg/dl
- Alkaline phosphatase (hepatic) > 3 times the upper normal limit
- Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper limit of normal
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, acute exacerbation of 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 and the light exposure precautions
- Any condition which in the Investigators' opinion deems the subject an unsuitable candidate to receive study drug and therapy
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: Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II
This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients.
OUTLINE:
Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.
- Conditions
- Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma
- Being tested
- Laboratory Biomarker Analysis, Photodynamic Therapy, Porfimer Sodium
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Lymphoid Interstitial Pneumonia, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Photodynamic TherapyDrug
Also called PDT, Photoradiation Therapy
Undergo image-guided I-PDT
Porfimer SodiumDrug
Also called CL-184116, DHE, Dihematoporphyrin Ester, Dihematoporphyrin Ether
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (porfimer sodium, image-guided I-PDT) | Experimental | Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. Receives: Other: Laboratory Biomarker Analysis; Drug: Photodynamic Therapy; Drug: Porfimer Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Up to 12 months
Secondary outcomes (1)
Serum Alkaline DNase (SADA) Activity
SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study start1 Apr 2014
- Primary completion13 Oct 2016
- Study completion4 Nov 2016
Why it stopped: Study no longer has an active IDE
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 Recurrent Laryngeal Squamous Cell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 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
- Hassan Arshad, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068157
- Sponsor's protocol ID
- I 235613
- Other IDs
- NCI-2014-00210, I 235613, P30CA016056
- Status last verified
- Sep 2017
- First submitted
- 18 Feb 2014
- Last updated
- 11 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II
- ClinicalTrials.gov ID
- NCT02068157
- Acronym / sponsor ID
- I 235613
- Conditions
- Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study no longer has an active IDE
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Posted 28 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.
Detailed description
PRIMARY OBJECTIVES:
- Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients.
OUTLINE:
Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (porfimer sodium, image-guided I-PDT) | Experimental | Other: Laboratory Biomarker Analysis, Drug: Photodynamic Therapy, Drug: Porfimer SodiumPatients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Histologically confirmed recurrent squamous cell carcinoma of the oral cavity, pharynx, (oropharynx, larynx) and neck
- Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
- Patients on chemotherapy \&/or targeted agents for palliation
- Life expectancy of at least 6 months in the judgment of the physician
Key exclusion criteria (15 listed)
- Radiotherapy within the last 2 months in the area to be treated
- Patients with known brain metastases should be excluded from this clinical trial
- Tumor invading a major blood vessel (such as the carotid artery)
- Tumor is not clearly shown on a computed tomography (CT) scan
- Location and extension of the tumor precludes an effective I-PDT
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (porfimer sodium, image-guided I-PDT) |
| Photodynamic TherapyAlso: PDT, Photoradiation TherapyUndergo image-guided I-PDT | Drug | Treatment (porfimer sodium, image-guided I-PDT) |
| Porfimer SodiumAlso: CL-184116, DHE, Dihematoporphyrin Ester, Dihematoporphyrin EtherGiven IV | Drug | Treatment (porfimer sodium, image-guided I-PDT) |
Primary outcome
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
Time frame: Up to 12 months
Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
1 secondary outcome
Serum Alkaline DNase (SADA) Activity
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
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Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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Head and Neck Squamous Cell Carcinoma
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.
Hassan Arshad 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 Laboratory Biomarker Analysis, Photodynamic Therapy and Porfimer Sodium in people with Recurrent Laryngeal Squamous Cell Carcinoma and Recurrent Laryngeal Verrucous 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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 11 Oct 2017. 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 28 Aug 2017). 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?
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1 (time frame: Up to 12 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 11 Oct 2017.