Head and Neck CancerPhase 2NCT00002964
Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
A Phase 2 study testing porfimer sodium and fluorophotometry in people with Head and Neck Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs that make cancer cells more visible to light may help in the diagnosis of head and neck cancer. PURPOSE: Phase II trial to study the usefulness of porfimer sodium in diagnosing patients with head and neck cancer. 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 fluorophotometry
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 1995to Apr 2004
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS: Malignant or suspected lesions of the head and neck that are scheduled for excisional biopsy Lesions no greater than 2 cm in diameter in the mouth, oropharynx, hypopharynx or larynx Suspected severe dysplasia, carcinoma in situ and/or invasive carcinoma of the head and neck
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3500/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Alkaline phosphatase no greater than 2 times upper limit of normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: No known hypersensitivity to porphyrins Not pregnant Fertile patients must use effective birth control
PRIOR CONCURRENT THERAPY: Not specified
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: Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light
RATIONALE: Drugs that make cancer cells more visible to light may help in the diagnosis of head and neck cancer.
PURPOSE: Phase II trial to study the usefulness of porfimer sodium in diagnosing patients with head and neck cancer.
Read the detailed description
OBJECTIVES: I. Determine whether porfimer sodium fluorescence can be used to reveal early malignant changes in patients with lesions of the oral cavity. II. Investigate whether porfimer sodium fluorescence can define areas of field cancerization in the oral mucosa, specifically satellite foci of malignant cells within the margins of an excision. III. Determine whether uptake of fluorescence is indicative of disease stage.
OUTLINE: Patients receive porfimer sodium IV bolus and are kept in subdued light until examination with a fluorescence photometer 48 hours later. Patients must avoid sunlight and other intense lights for an additional 30 days.
PROJECTED ACCRUAL: 20 patients will be accrued per year.
- Conditions
- Head and Neck Cancer
- Being tested
- porfimer sodium, fluorophotometry
- Keywords
- stage 0 oropharyngeal cancer, stage 0 laryngeal cancer, stage 0 hypopharyngeal cancer, stage 0 lip and oral cavity cancer, stage I lip and oral cavity cancer, stage I hypopharyngeal cancer, stage I laryngeal cancer, stage I oropharyngeal cancer
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Hypopharyngeal Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
porfimer sodiumDrug
fluorophotometryOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2004 (estimated)
- Study startFeb 1995
- Primary completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Diagnosis
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Wesley L. Hicks, MD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002964
- Sponsor's protocol ID
- DS 94-10
- Other IDs
- RPCI-DS-94-10, NCI-V97-1196
- Status last verified
- Feb 2013
- First submitted
- 1 Nov 1999
- Last updated
- 5 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light
- ClinicalTrials.gov ID
- NCT00002964
- Acronym / sponsor ID
- DS 94-10
- Conditions
- Head and Neck Cancer
- Keywords
- stage 0 oropharyngeal cancer, stage 0 laryngeal cancer, stage 0 hypopharyngeal cancer, stage 0 lip and oral cavity cancer, stage I lip and oral cavity cancer, stage I hypopharyngeal cancer, stage I laryngeal cancer, stage I oropharyngeal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Feb 1995
- Primary completion
- Apr 2004 (actual)
- First posted
- 27 Apr 2004 (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.
RATIONALE: Drugs that make cancer cells more visible to light may help in the diagnosis of head and neck cancer.
PURPOSE: Phase II trial to study the usefulness of porfimer sodium in diagnosing patients with head and neck cancer.
Detailed description
OBJECTIVES: I. Determine whether porfimer sodium fluorescence can be used to reveal early malignant changes in patients with lesions of the oral cavity. II. Investigate whether porfimer sodium fluorescence can define areas of field cancerization in the oral mucosa, specifically satellite foci of malignant cells within the margins of an excision. III. Determine whether uptake of fluorescence is indicative of disease stage.
OUTLINE: Patients receive porfimer sodium IV bolus and are kept in subdued light until examination with a fluorescence photometer 48 hours later. Patients must avoid sunlight and other intense lights for an additional 30 days.
PROJECTED ACCRUAL: 20 patients will be accrued per year.
Study design
- Primary purpose
- Diagnosis
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 sodium | Drug | – |
| fluorophotometry | Other | – |
Primary outcome
Not reported in the source record.
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 5 Feb 2013.
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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.
Wesley L. Hicks, MD study chair
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 porfimer sodium and fluorophotometry 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: finished, as of the sponsor's last update on 5 Feb 2013. 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?
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.
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 5 Feb 2013.