Head and Neck CancerPhase 1NCT00675233
Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx
A Phase 1 study testing HPPH and laser therapy 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, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal 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?
- HPPH and laser therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2008to 27 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Biopsy-confirmed diagnosis of 1 of the following:
- Mild to severe dysplasia of the larynx
- Dysplastic lesions > 3 mm in thickness
- Squamous cell carcinoma in situ of the larynx
- T1 squamous cell carcinoma of the larynx
- Tumor > 3 mm in thickness
- No T2-T4 squamous cell carcinoma of the larynx
- Newly diagnosed or recurrent disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Total bilirubin > 2.0 mg/dL
- Creatinine > 2.0 mg/dL
- SGOT > 3 times upper limit of normal (ULN)
- Alkaline phosphatase > 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment
- No porphyria
- No hypersensitivity to porphyrin or porphyrin-like compounds
PRIOR CONCURRENT THERAPY:
- Any prior therapy allowed
- At least 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: Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx.
Secondary
- To determine response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of laser light therapy.
Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.
- Conditions
- Head and Neck Cancer
- Being tested
- HPPH, laser therapy
- Keywords
- recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage 0 laryngeal cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPPHDrug
Given IV
laser therapyProcedure or surgery
Escalating light doses with 665 nm light
| Study group | Role | What they receive |
|---|---|---|
| Treatment PDT | Experimental | Patients undergo PDT comprising HPPH IV over 1 hour on day 1 followed by laser light to the tumor on day 2. At least 6 weeks later, patients achieving partial response, no response, or a geographical miss may undergo a second course of treatment. Receives: Drug: HPPH; Procedure: laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Measured: 6 weeks
Tumor response
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study start25 Apr 2008
- Primary completion28 Jun 2013
- Study completion27 Sep 2018
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan Arshad, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675233
- Sponsor's protocol ID
- CDR0000595166
- Other IDs
- I 119207
- Status last verified
- Oct 2018
- First submitted
- 8 May 2008
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx
- ClinicalTrials.gov ID
- NCT00675233
- Acronym / sponsor ID
- CDR0000595166
- Conditions
- Head and Neck Cancer
- Keywords
- recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage 0 laryngeal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 25 Apr 2008 (actual)
- Primary completion
- 28 Jun 2013 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 9 May 2008 (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, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx.
Secondary
- To determine response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of laser light therapy.
Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment PDT | Experimental | Drug: HPPH, Procedure: laser therapyPatients undergo PDT comprising HPPH IV over 1 hour on day 1 followed by laser light to the tumor on day 2. At least 6 weeks later, patients achieving partial response, no response, or a geographical miss may undergo a second course of treatment. |
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 |
|---|---|---|
| HPPHGiven IV | Drug | Treatment PDT |
| laser therapyEscalating light doses with 665 nm light | Procedure or surgery | Treatment PDT |
Primary outcome
Toxicity
Time frame: 6 weeks
Tumor response
Time frame: 3 months
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 17 Oct 2018.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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
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 HPPH and laser therapy 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 17 Oct 2018. 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?
Toxicity (time frame: 6 weeks). 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 17 Oct 2018.