Stage I Oral Cavity Squamous Cell CarcinomaPhase 2NCT03090412
Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer
A Phase 2 study testing HPPH, Laboratory Biomarker Analysis and Photodynamic Therapy in people with Stage I Oral Cavity Squamous Cell Carcinoma and Stage II Oral Cavity Squamous Cell Carcinoma, run by Roswell Park Cancer Institute at 2 sites in United States.
Trial summary
This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works compared to standard of care surgery in treating patients with oral cavity cancer. Photodynamic therapy can destroy or control disease by using a combination of drug, such as HPPH, and light and may be as effective as surgery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Oral Cavity Squamous Cell Carcinoma, Stage II Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- HPPH, Laboratory Biomarker Analysis and Photodynamic Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2018to 6 Aug 2021
- Phase
- Phase 2
- 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
Who may be able to join
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Participants with previously untreated T1/T2 N0 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx
- Histologically confirmed squamous cell carcinoma of the target tumor(s)
- Tumor thickness is 4 mm or less (measured clinically and/or by computed tomography [CT] or magnetic resonance imaging [MRI] scan)
- CT or MRI of the neck to confirm staging
- Tumor accessible for unrestricted illumination for photodynamic therapy (PDT) (accessibility as determined by the physician)
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- Life expectancy of at least 12 months in the judgment of the physician
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
- Participant or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Those who have had chemotherapy or radiotherapy or targeted agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Those with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Those with porphyria or with known hypersensitivity to porphyrins or porphyrin-like compounds
- White blood cells (WBC) < 4,000
- Total serum bilirubin > 2 mg/dL
- Serum creatinine > 2 mg/dL
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- Alkaline phosphatase (hepatic) or serum glutamic-oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
- Diagnostic biopsy reveals perineural invasion (PNI) and/or lymphovascular invasion (LVI)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Nodal disease as detected by clinical exam or CT
- Pregnant or nursing females
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
- Received an investigational agent within 30 days prior to enrollment
- Trismus or compromised airway
- Previous treatment in the target tumor area
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Rocherster
Rochester, New York, 14642
About this study
Official title: A Randomized Multicenter Phase II Study Using (2-1[Heyloxyethyl]-2-Devinylpyropheophorbide-a) (HPPH) With PDT Versus Standard of Care Surgery for Patients With T1/T2 N0 Squamous Cell Carcinoma of the Oral Cavity
This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works compared to standard of care surgery in treating patients with oral cavity cancer. Photodynamic therapy can destroy or control disease by using a combination of drug, such as HPPH, and light and may be as effective as surgery in treating patients with oral cavity cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery by comparing the rate of tumor response after PDT to those observed after surgery, at 24 months post treatment.
SECONDARY OBJECTIVES:
- To determine quality of life (QoL) at 6, 12, 18 and 24 months post PDT or surgery.
II. To assess the toxicity using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0).
TERTIARY OBJECTIVES:
- Immune markers (T cells). II. To investigate the correlation of the diffuse reflectance optical spectroscopy with tumor response to PDT.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo standard of care surgery on day 1.
ARM II: Patients receive HPPH intravenously (IV) over 1 hour on day 0 and undergo PDT on day 1.
After completion of study treatment, patients are followed up every 3-4 months in year 1 and every 3-6 months in year 2.
- Being tested
- HPPH, Laboratory Biomarker Analysis, Photodynamic Therapy, Quality-of-Life Assessment, Therapeutic Conventional Surgery
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPPHDrug
Also called Photochlor
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Photodynamic TherapyDrug
Also called PDT, Photoradiation Therapy
Undergo PDT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Therapeutic Conventional SurgeryProcedure or surgery
Undergo standard of care surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I (surgery) | Experimental | Patients undergo standard of care surgery on day 1. Receives: Other: Quality-of-Life Assessment; Procedure: Therapeutic Conventional Surgery |
| Arm II (HPPH, PDT) | Experimental | Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1. Receives: Drug: HPPH; Other: Laboratory Biomarker Analysis; Drug: Photodynamic Therapy; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1
Objective tumor response will be tabulated overall.
Measured: At 24 months
Secondary outcomes (2)
Change in Quality of Life as Measured by the University of Washington Quality of Life Questionnaire Version 4
In the analysis of QoL simple data analyses will initially take place including individual participant-level profile plots and overall mean plots used to examining the mean structure. Formal statistical examination of longitudinal patterns will be done through the use of a mixed model. Once the model is fit, specific linear contrasts based on the estimated model parameters will be constructed and used to test hypotheses concerning between time points and between group comparisons
Measured: Baseline up to 24 months
Adverse Events as Graded by CTCAE Version 4.0 Are Reported
The frequency of toxicities will be tabulated by grade.
Measured: Up to 30 days after administration of HPPH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start7 Mar 2018
- Primary completion1 Aug 2021
- Study completion6 Aug 2021
Why it stopped: low accrual
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.
- Other trials for Stage I Oral Cavity Squamous Cell CarcinomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 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
- Jon Chan, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090412
- Sponsor's protocol ID
- I 33616
- Other IDs
- NCI-2017-00441, I 33616, P30CA016056
- Status last verified
- May 2022
- First submitted
- 20 Mar 2017
- Last updated
- 2 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Phase II Study Using (2-1[Heyloxyethyl]-2-Devinylpyropheophorbide-a) (HPPH) With PDT Versus Standard of Care Surgery for Patients With T1/T2 N0 Squamous Cell Carcinoma of the Oral Cavity
- ClinicalTrials.gov ID
- NCT03090412
- Acronym / sponsor ID
- I 33616
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 2 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works compared to standard of care surgery in treating patients with oral cavity cancer. Photodynamic therapy can destroy or control disease by using a combination of drug, such as HPPH, and light and may be as effective as surgery in treating patients with oral cavity cancer.
Detailed description
PRIMARY OBJECTIVES:
- To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery by comparing the rate of tumor response after PDT to those observed after surgery, at 24 months post treatment.
SECONDARY OBJECTIVES:
- To determine quality of life (QoL) at 6, 12, 18 and 24 months post PDT or surgery.
II. To assess the toxicity using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0).
TERTIARY OBJECTIVES:
- Immune markers (T cells). II. To investigate the correlation of the diffuse reflectance optical spectroscopy with tumor response to PDT.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo standard of care surgery on day 1.
ARM II: Patients receive HPPH intravenously (IV) over 1 hour on day 0 and undergo PDT on day 1.
After completion of study treatment, patients are followed up every 3-4 months in year 1 and every 3-6 months in year 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (surgery) | Experimental | Other: Quality-of-Life Assessment, Procedure: Therapeutic Conventional SurgeryPatients undergo standard of care surgery on day 1. |
| Arm II (HPPH, PDT) | Experimental | Drug: HPPH, Other: Laboratory Biomarker Analysis, Drug: Photodynamic Therapy, Other: Quality-of-Life AssessmentPatients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Participants with previously untreated T1/T2 N0 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx
- Histologically confirmed squamous cell carcinoma of the target tumor(s)
- Tumor thickness is 4 mm or less (measured clinically and/or by computed tomography [CT] or magnetic resonance imaging [MRI] scan)
- CT or MRI of the neck to confirm staging
Key exclusion criteria (16 listed)
- Those who have had chemotherapy or radiotherapy or targeted agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Those with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Those with porphyria or with known hypersensitivity to porphyrins or porphyrin-like compounds
- White blood cells (WBC) < 4,000
- Total serum bilirubin > 2 mg/dL
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 |
|---|---|---|
| HPPHAlso: PhotochlorGiven IV | Drug | Arm II (HPPH, PDT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm II (HPPH, PDT) |
| Photodynamic TherapyAlso: PDT, Photoradiation TherapyUndergo PDT | Drug | Arm II (HPPH, PDT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (surgery), Arm II (HPPH, PDT) |
| Therapeutic Conventional SurgeryUndergo standard of care surgery | Procedure or surgery | Arm I (surgery) |
Primary outcome
Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1
Time frame: At 24 months
Objective tumor response will be tabulated overall.
2 secondary outcomes
Change in Quality of Life as Measured by the University of Washington Quality of Life Questionnaire Version 4
Time frame: Baseline up to 24 months
Adverse Events as Graded by CTCAE Version 4.0 Are Reported
Time frame: Up to 30 days after administration of HPPH
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jon Chan principal investigator
Roswell Park Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HPPH, Laboratory Biomarker Analysis and Photodynamic Therapy in people with Stage I Oral Cavity Squamous Cell Carcinoma and Stage II Oral Cavity Squamous Cell Carcinoma, run by Roswell Park Cancer Institute at 2 sites 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 16 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: stopped early, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 2 Jun 2022). 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?
Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1 (time frame: At 24 months). 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 2 Jun 2022.