Recurrent Squamous Cell Carcinoma of the Lip and Oral CavityNCT01718223
Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer
A study testing photodynamic therapy, therapeutic conventional surgery and laboratory biomarker analysis in people with Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity and Recurrent Squamous Cell Carcinoma of the Oropharynx, run by Roswell Park Cancer Institute.
Trial summary
This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Verrucous Carcinoma of the Oral Cavity
- What is being tested?
- photodynamic therapy, therapeutic conventional surgery and laboratory biomarker analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Aug 2014
- Phase
- Interventional
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the oropharynx or oral cavity that are amenable to surgery
- Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
- Life expectancy of at least 6 months in the judgment of the physician
- Blood urea nitrogen (BUN) =< upper limit of normal (ULN)
- White blood count > 3,000 per microliter or
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- Absolute neutrophil count (ANC) > 1500 per microliter
- Serum calcium within normal limits; note: serum calcium will be corrected for low albumin, if necessary
- 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 the duration of study participation; 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
- Subjects who have had radiotherapy within the last 3 months
- Subjects with known brain metastases should be excluded from this clinical trial
- Tumor invading a major blood vessel (such as the carotid artery)
- Tumor invading the skull base
- Subjects with ophthalmic disease
- Tumor is not clearly shown on an imaging scan/location and extension of tumor that precludes effective PDT, in the judgment of the primary investigator (PI)
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- Location and extension of the tumor precludes an effective interstitial photodynamic therapy (iPDT)
- Patients with known hypersensitivity to porphyrins or with porphyria
- Has distant metastasis that decreases life expectancy to less than 6 months
- 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 and the light exposure precautions
- Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
About this study
Official title: A Pilot Study of Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity
This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy uses a drug, such as temoporfin, 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 using temoporfin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
SECONDARY OBJECTIVES:
- Quantify the relationship between the measured intra-tumor light dose and the pathological tumor response.
TERTIARY OBJECTIVES:
- Simulate light dose distribution within the treated tumor. II. Immune markers.
OUTLINE:
Patients receive temoporfin intravenously (IV) over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.
After completion of study treatment, patients are followed for 3 years.
- Conditions
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Verrucous Carcinoma of the Oral Cavity
- Being tested
- photodynamic therapy, therapeutic conventional surgery, laboratory biomarker analysis, temoporfin
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photodynamic therapyDrug
Also called Light Infusion Therapy™, PDT, therapy, photodynamic
Undergo interstitial photodynamic therapy using temoporfin
therapeutic conventional surgeryProcedure or surgery
Undergo surgical resection
laboratory biomarker analysisOther
Correlative studies
temoporfinDrug
Also called Foscan, m-tetrahydroxyphenyl-chlorin, mTHPC
Undergo interstitial photodynamic therapy using temoporfin
| Study group | Role | What they receive |
|---|---|---|
| Treatment (interstitial photodynamic therapy using temoporfin) | Experimental | Patients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection. Receives: Drug: photodynamic therapy; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Drug: temoporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events, graded according to NCI CTCAE version 4.0
The frequency of toxicities will be tabulated by grade.
Measured: Up to 30 days after surgical resection
Secondary outcomes (2)
Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system
Measured: Day 3
Ratio of the viable/nonviable tissue in the resected tumor, ex vivo
The area of viable and necrotic tumor will be measured by the number of field of view (1 FOV = 0.196 mm^2), microscopic area using a 40x objective.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: implementation issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Squamous Cell Carcinoma of the Lip and Oral CavityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Biolitec Pharma Ltd.
- Responsible party
- Sponsor
- Investigators
- Hassan Arshad, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718223
- Sponsor's protocol ID
- I 217512
- Other IDs
- NCI-2012-01879
- Status last verified
- Sep 2014
- First submitted
- 29 Oct 2012
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity
- ClinicalTrials.gov ID
- NCT01718223
- Acronym / sponsor ID
- I 217512
- Conditions
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Verrucous Carcinoma of the Oral Cavity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: implementation issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Biolitec Pharma Ltd.
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 31 Oct 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 pilot clinical trial studies photodynamic therapy using temoporfin before surgery in treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy uses a drug, such as temoporfin, 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 using temoporfin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed description
PRIMARY OBJECTIVES:
- To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
SECONDARY OBJECTIVES:
- Quantify the relationship between the measured intra-tumor light dose and the pathological tumor response.
TERTIARY OBJECTIVES:
- Simulate light dose distribution within the treated tumor. II. Immune markers.
OUTLINE:
Patients receive temoporfin intravenously (IV) over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.
After completion of study treatment, patients are followed for 3 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 (interstitial photodynamic therapy using temoporfin) | Experimental | Drug: photodynamic therapy, Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysis, Drug: temoporfinPatients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the oropharynx or oral cavity that are amenable to surgery
- Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
- Life expectancy of at least 6 months in the judgment of the physician
- Blood urea nitrogen (BUN) =< upper limit of normal (ULN)
Key exclusion criteria (13 listed)
- Subjects who have had radiotherapy within the last 3 months
- Subjects with known brain metastases should be excluded from this clinical trial
- Tumor invading a major blood vessel (such as the carotid artery)
- Tumor invading the skull base
- Subjects with ophthalmic disease
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 |
|---|---|---|
| photodynamic therapyAlso: Light Infusion Therapy™, PDT, therapy, photodynamicUndergo interstitial photodynamic therapy using temoporfin | Drug | Treatment (interstitial photodynamic therapy using temoporfin) |
| therapeutic conventional surgeryUndergo surgical resection | Procedure or surgery | Treatment (interstitial photodynamic therapy using temoporfin) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (interstitial photodynamic therapy using temoporfin) |
| temoporfinAlso: Foscan, m-tetrahydroxyphenyl-chlorin, mTHPCUndergo interstitial photodynamic therapy using temoporfin | Drug | Treatment (interstitial photodynamic therapy using temoporfin) |
Primary outcome
Frequency of adverse events, graded according to NCI CTCAE version 4.0
Time frame: Up to 30 days after surgical resection
The frequency of toxicities will be tabulated by grade.
2 secondary outcomes
Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system
Time frame: Day 3
Ratio of the viable/nonviable tissue in the resected tumor, ex vivo
Time frame: Up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 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.
Hassan Arshad, MD principal investigator
Roswell Park Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing photodynamic therapy, therapeutic conventional surgery and laboratory biomarker analysis in people with Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity and Recurrent Squamous Cell Carcinoma of the Oropharynx, run by Roswell Park Cancer Institute.
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 10 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: withdrawn, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Frequency of adverse events, graded according to NCI CTCAE version 4.0 (time frame: Up to 30 days after surgical resection). 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 3 Sep 2014.