DysplasiaPhase 1NCT01140178
A Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx
A Phase 1 study testing HPPH in people with Dysplasia and Carcinoma of the Oral Cavity, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
Recent literature suggests that certain patients with squamous cell cancers of the head and neck region may benefit from photodynamic therapy whether or not they may have received prior therapy, e.g. radiation therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysplasia, Carcinoma of the Oral Cavity, Carcinoma of the Oropharynx
- What is being tested?
- HPPH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2010to 1 Oct 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
Who may be able to join
- Patients with moderate to severe dysplasia and/or squamous carcinoma-in-situ of the oral cavity and/or oropharynx.
- Patients with T1 squamous cell carcinoma of the oral cavity and/or oropharynx.
- Patient may have primary and/or recurrent lesions to be treated.
- Diagnosis must confirmed by biopsy.
- Prior therapy of any type is allowed.
- Male or female patients at least 18 years old. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal. Male patients should be using a medically acceptable form of birth control or be sterile.
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- Patients must have an ECOG score of 0-2 (Appendix A 1 ).
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
- Both men and women and members of all races and ethnic groups are eligible for this study.
Who cannot join
- Patients with T2 or greater squamous cell carcinoma.
- True tongue base lesions (as determined by the treating physician).
- Patients with severe trismus that prevents adequate access to the lesion for treatment light delivery (as determined by the treating physician).
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
- Patients with impaired hepatic (alkaline phosphatase (hepatic) or SGOT;:3 times the upper normal limits).
- Patients with minimal impairment of renal function (total serum bilirubin;: 2 mg/dl, serum creatinine;: 2 mg/dl)
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- Unwilling or unable to follow protocol requirements.
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug and or light treatment.
- Patients on concurrent chemotherapy or radiation therapy or less than 4 weeks after the last dose of chemotherapy or radiation therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Phase la Trial of Photodynamic Therapy With HPPH (2-1 (Hexyloxyethyl)-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx.
Recent literature suggests that certain patients with squamous cell cancers of the head and neck region may benefit from photodynamic therapy whether or not they may have received prior therapy, e.g. radiation therapy
Read the detailed description
We propose to initiate a Phase 1 a clinical trial using HPPH and 665 nm light in patients with cancer of the oral cavity and/or oropharynx, including lesions of moderate to severe dysplasia, squamous carcinoma in situ and T1 squamous cells carcinoma. The study will employ a fixed HPPH dose of 4 mg/m2 infused over 1 hour, and 24 hours later light doses escalating from 100 J/cm2 to 125 and 140 J/cm2, respectively. The primary goal is the determination of the maximally tolerated PDT dose. Preliminary evidence for PDT efficacy wil also be obtained.
- Being tested
- HPPH
- Keywords
- Photodynamic Therapy, Oral dysplasia, oral cavity carcinoma, oropharynx carcinoma.
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPPHDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| HPPH | Experimental | a fixed HPPH dose of 4 mg/m2 infused over 1 hour, and 24 hours later light doses escalating from 100 J/cm2 to 125 and 140 J/cm2, respectively. Receives: Drug: HPPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
To determine the maximally tolerated dose in the oral cavity and/or oropharynx of photodynamic therapy (PDT) using HPPH (2-1 (hexyloxyethyl)-2- devinylpyropheophorbide-a) and 665 nm light.
Measured: 6 weeks
Secondary outcomes (5)
Tumor response
Measured: 3 months
Response of dysplasia, CiS and selected patients with T1 squamous cell carcinoma of the oral cavity and/or oropharynx using photodynamic therapy (PDT) with HPPH (2-1 (hexyloxyethyl)-2-devinylpyropheophorbide-a) and 665 nm light.
Measured: 3 months
Amount of HPPH in the blood prior to light treatment.
Measured: 3 months
Biomarkers, i.e. STAT3 crosslinks and/or activation status of pro-survival signaling molecules before and after PDT treatment.
Measured: 3 months
To determine non-invasively HPPH fluorescence and blood flow in To determine non-invasively HPPH fluorescence and blood flow in tumor and surrounding normal tissue before and after PDT
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 Jun 2010 (estimated)
- Study start8 Jun 2010
- Primary completion29 Jan 2013
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysplasiaStudies 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
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hassan Arshad, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140178
- Sponsor's protocol ID
- I 170910
- Status last verified
- Oct 2018
- First submitted
- 7 Jun 2010
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase la Trial of Photodynamic Therapy With HPPH (2-1 (Hexyloxyethyl)-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx.
- ClinicalTrials.gov ID
- NCT01140178
- Acronym / sponsor ID
- I 170910
- Keywords
- Photodynamic Therapy, Oral dysplasia, oral cavity carcinoma, oropharynx carcinoma.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jun 2010 (actual)
- Primary completion
- 29 Jan 2013 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 9 Jun 2010 (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.
Recent literature suggests that certain patients with squamous cell cancers of the head and neck region may benefit from photodynamic therapy whether or not they may have received prior therapy, e.g. radiation therapy
Detailed description
We propose to initiate a Phase 1 a clinical trial using HPPH and 665 nm light in patients with cancer of the oral cavity and/or oropharynx, including lesions of moderate to severe dysplasia, squamous carcinoma in situ and T1 squamous cells carcinoma. The study will employ a fixed HPPH dose of 4 mg/m2 infused over 1 hour, and 24 hours later light doses escalating from 100 J/cm2 to 125 and 140 J/cm2, respectively. The primary goal is the determination of the maximally tolerated PDT dose. Preliminary evidence for PDT efficacy wil also be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPPH | Experimental | Drug: HPPHa fixed HPPH dose of 4 mg/m2 infused over 1 hour, and 24 hours later light doses escalating from 100 J/cm2 to 125 and 140 J/cm2, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with moderate to severe dysplasia and/or squamous carcinoma-in-situ of the oral cavity and/or oropharynx.
- Patients with T1 squamous cell carcinoma of the oral cavity and/or oropharynx.
- Patient may have primary and/or recurrent lesions to be treated.
- Diagnosis must confirmed by biopsy.
- Prior therapy of any type is allowed.
Key exclusion criteria (9 listed)
- Patients with T2 or greater squamous cell carcinoma.
- True tongue base lesions (as determined by the treating physician).
- Patients with severe trismus that prevents adequate access to the lesion for treatment light delivery (as determined by the treating physician).
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
- Patients with impaired hepatic (alkaline phosphatase (hepatic) or SGOT;:3 times the upper normal limits).
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 | HPPH |
Primary outcome
Toxicity
Time frame: 6 weeks
To determine the maximally tolerated dose in the oral cavity and/or oropharynx of photodynamic therapy (PDT) using HPPH (2-1 (hexyloxyethyl)-2- devinylpyropheophorbide-a) and 665 nm light.
5 secondary outcomes
Tumor response
Time frame: 3 months
Response of dysplasia, CiS and selected patients with T1 squamous cell carcinoma of the oral cavity and/or oropharynx using photodynamic therapy (PDT) with HPPH (2-1 (hexyloxyethyl)-2-devinylpyropheophorbide-a) and 665 nm light.
Time frame: 3 months
Amount of HPPH in the blood prior to light treatment.
Time frame: 3 months
Biomarkers, i.e. STAT3 crosslinks and/or activation status of pro-survival signaling molecules before and after PDT treatment.
Time frame: 3 months
To determine non-invasively HPPH fluorescence and blood flow in To determine non-invasively HPPH fluorescence and blood flow in tumor and surrounding normal tissue before and after PDT
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 16 Oct 2018.
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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
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 in people with Dysplasia and Carcinoma of the Oral Cavity, 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?
The sponsor lists 9 inclusion and 9 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: finished, as of the sponsor's last update on 16 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). 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 16 Oct 2018.