Head and Neck CancerNCT00530088
Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat
A study testing porfimer sodium and Photdynamic Therapy (PDT) in people with Head and Neck Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- porfimer sodium and Photdynamic Therapy (PDT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Oct 2010
- Phase
- Interventional
- 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 oral cavity or larynx lesion with mild-to-severe dysplasia OR in situ or stage I (T1, N0) squamous cell carcinoma of the oral cavity or larynx
- Recurrent disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- WBC ≥ 4,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 2.0 mg/dL
- Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
- SGOT ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must practice effective contraception
- No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
PRIOR CONCURRENT THERAPY:
- Any type of prior therapy allowed
- More than 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: Photodynamic Therapy With Photofrin® for Treatment of Dysplasia, Carcinoma In Situ and Stage I Carcinoma of the Oral Cavity and the Larynx: A Pilot Study
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat.
PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer of the mouth or throat, or stage I cancer of the mouth or throat.
Read the detailed description
OBJECTIVES:
- To determine the response of patients with recurrent dysplasia, squamous cell carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity or the larynx treated with photodynamic therapy using porfimer sodium.
- To identify the local toxicity of this treatment in these patients.
OUTLINE: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. Patients with incompletely treated or missed sites of disease may receive another dose of laser light on day 5 without additional porfimer sodium. Patients with multicentric disease may undergo additional PDT at least 4-6 weeks after the initial treatment.
After completion of study therapy, patients are followed for 1-2 months.
- Conditions
- Head and Neck Cancer
- Being tested
- porfimer sodium, Photdynamic Therapy (PDT)
- Keywords
- recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage 0 laryngeal cancer, stage 0 lip and oral cavity cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Laryngeal Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
porfimer sodiumDrug
IV
Photdynamic Therapy (PDT)Drug
| Study group | Role | What they receive |
|---|---|---|
| Porfimer Sodium | Experimental | Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. Receives: Drug: porfimer sodium; Drug: Photdynamic Therapy (PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy.
9.23 No Response. All responses less than a Partial Response are considered as No Response.
9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia.
Measured: 2 years
Local Toxicity
Number of patients with an adverse event
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startOct 2001
- Primary completionAug 2010
- Study completionOct 2010
Why it stopped: new competing studies
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nestor R. Rigual, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530088
- Sponsor's protocol ID
- CDR0000564841
- Other IDs
- RPCI-RPC-01-08
- Status last verified
- Jun 2014
- First submitted
- 13 Sep 2007
- Last updated
- 4 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rigual NR, Thankappan K, Cooper M, Sullivan MA, Dougherty T, Popat SR, Loree TR, Biel MA, Henderson B. Photodynamic therapy for head and neck dysplasia and cancer. Arch Otolaryngol Head Neck Surg. 2009 Aug;135(8):784-8. doi: 10.1001/archoto.2009.98.
PubMed 19687399
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy With Photofrin® for Treatment of Dysplasia, Carcinoma In Situ and Stage I Carcinoma of the Oral Cavity and the Larynx: A Pilot Study
- ClinicalTrials.gov ID
- NCT00530088
- Acronym / sponsor ID
- CDR0000564841
- Conditions
- Head and Neck Cancer
- Keywords
- recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage 0 laryngeal cancer, stage 0 lip and oral cavity cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new competing studies
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Posted 4 Jul 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 that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat.
PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer of the mouth or throat, or stage I cancer of the mouth or throat.
Detailed description
OBJECTIVES:
- To determine the response of patients with recurrent dysplasia, squamous cell carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity or the larynx treated with photodynamic therapy using porfimer sodium.
- To identify the local toxicity of this treatment in these patients.
OUTLINE: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. Patients with incompletely treated or missed sites of disease may receive another dose of laser light on day 5 without additional porfimer sodium. Patients with multicentric disease may undergo additional PDT at least 4-6 weeks after the initial treatment.
After completion of study therapy, patients are followed for 1-2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Porfimer Sodium | Experimental | Drug: porfimer sodium, Drug: Photdynamic Therapy (PDT)Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. |
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 |
|---|---|---|
| porfimer sodiumIV | Drug | Porfimer Sodium |
| Photdynamic Therapy (PDT) | Drug | Porfimer Sodium |
Primary outcome
Response
Time frame: 2 years
Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy. 9.23 No Response. All responses less than a Partial Response are considered as No Response. 9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia.
Local Toxicity
Time frame: 30 days
Number of patients with an adverse event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19687399Rigual NR, Thankappan K, Cooper M, Sullivan MA, Dougherty T, Popat SR, Loree TR, Biel MA, Henderson B. Photodynamic therapy for head and neck dysplasia and cancer. Arch Otolaryngol Head Neck Surg. 2009 Aug;135(8):784-8. doi: 10.1001/archoto.2009.98.
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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.
Nestor R. Rigual, 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 study testing porfimer sodium and Photdynamic Therapy (PDT) in people with Head and Neck 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 4 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 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?
Response (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00530088, which also lists 1 linked publication.
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 4 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.