Head and Neck CancerPhase 1NCT00978081
Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
A Phase 1 study testing aminolevulinic acid hydrochloride in people with Head and Neck Cancer and Precancerous Condition, run by Abramson Cancer Center at Penn Medicine 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. PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer, Precancerous Condition
- What is being tested?
- aminolevulinic acid hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2016
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following within the past 3 months:
- Erythroplakia with dysplasia
- Severe dysplasia
- Carcinoma in situ of the head and neck for which standard therapy is not indicated, according to any of the following:
- Medical condition that precludes surgery
- Lesions that cannot be completely resected based on size or location
- Significant functional morbidity would be anticipated with further surgery
- Refused standard therapy after the treatment has been discussed and offered
- No invasive squamous cell carcinoma of the head and neck
PATIENT CHARACTERISTICS:
- ECOG performance status of 0-2
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- AST or ALT ≤ 2 times ULN
- Alkaline phosphatase ≤ 2 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior chronic liver disease or cirrhosis of the liver
- No porphyria or hypersensitivity to porphyrins
- No significant cardiovascular history that, in the opinion of a cardiologist, would deem the patient at risk for hypotension that may occur with oral administration of aminolevulinic acid (Levulan®)
- No prior adverse reaction to ondansetron or lorazepam
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors
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.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic therapy when administered continuously or in fractionated doses in patients with premalignant or early stage head and neck lesions.
Secondary
- To assess the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of photodynamic therapy. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
- Arm II: Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.
After completion of study therapy, patients are followed up at 1 month, every 3 months for 2 years, and then annually thereafter.
- Conditions
- Head and Neck Cancer, Precancerous Condition
- Being tested
- aminolevulinic acid hydrochloride
- Keywords
- precancerous condition, stage 0 hypopharyngeal cancer, stage 0 laryngeal cancer, stage 0 lip and oral cavity cancer, stage 0 nasopharyngeal cancer, stage 0 oropharyngeal cancer, stage 0 paranasal sinus and nasal cavity cancer
- Medical subject headings
- Head and Neck Neoplasms, Precancerous Conditions, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Nasopharyngeal Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aminolevulinic acid hydrochlorideDrug
Patients undergo continuous or fractionated photodynamic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later. Receives: Drug: aminolevulinic acid hydrochloride |
| Arm II | Experimental | Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later. Receives: Drug: aminolevulinic acid hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Measured: One year
Maximum tolerated dose
Measured: 90 days
Secondary outcomes (3)
Response rate
Measured: One year
Duration of response
Measured: One year
Time to progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2016
- Study completionNov 2016
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 Abramson Cancer Center at Penn MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter Ahn, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978081
- Sponsor's protocol ID
- CDR0000650536
- Other IDs
- UPCC-18308, IRB #809093
- Status last verified
- Apr 2019
- First submitted
- 15 Sep 2009
- Last updated
- 23 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT00978081
- Acronym / sponsor ID
- CDR0000650536
- Conditions
- Head and Neck Cancer, Precancerous Condition
- Keywords
- precancerous condition, stage 0 hypopharyngeal cancer, stage 0 laryngeal cancer, stage 0 lip and oral cavity cancer, stage 0 nasopharyngeal cancer, stage 0 oropharyngeal cancer, stage 0 paranasal sinus and nasal cavity cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2009
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Sep 2009 (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: 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.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.
Detailed description
OBJECTIVES:
Primary
- To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic therapy when administered continuously or in fractionated doses in patients with premalignant or early stage head and neck lesions.
Secondary
- To assess the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of photodynamic therapy. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
- Arm II: Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.
After completion of study therapy, patients are followed up at 1 month, every 3 months for 2 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: aminolevulinic acid hydrochloridePatients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later. |
| Arm II | Experimental | Drug: aminolevulinic acid hydrochloridePatients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later. |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| aminolevulinic acid hydrochloridePatients undergo continuous or fractionated photodynamic therapy. | Drug | Arm I, Arm II |
Primary outcome
Dose-limiting toxicity
Time frame: One year
Maximum tolerated dose
Time frame: 90 days
3 secondary outcomes
Response rate
Time frame: One year
Duration of response
Time frame: One year
Time to progression
Time frame: 2 years
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 23 Apr 2019.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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.
Peter Ahn, MD principal investigator
Abramson Cancer Center at Penn Medicine
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 aminolevulinic acid hydrochloride in people with Head and Neck Cancer and Precancerous Condition, run by Abramson Cancer Center at Penn Medicine 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 23 Apr 2019. 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?
Dose-limiting toxicity (time frame: One year). 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?
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 23 Apr 2019.