- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03090412
Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer
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
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. 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:
I. 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:
I. 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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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Rochester, New York, United States, 14642
- University of Rocherster
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (surgery)
Patients undergo standard of care surgery on day 1.
|
Ancillary studies
Other Names:
Undergo standard of care surgery
|
Experimental: Arm II (HPPH, PDT)
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
|
Correlative studies
Ancillary studies
Other Names:
Given IV
Other Names:
Undergo PDT
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1
Time Frame: At 24 months
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Objective tumor response will be tabulated overall.
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At 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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Baseline up to 24 months
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Adverse Events as Graded by CTCAE Version 4.0 Are Reported
Time Frame: Up to 30 days after administration of HPPH
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The frequency of toxicities will be tabulated by grade.
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Up to 30 days after administration of HPPH
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jon Chan, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 33616 (Other Identifier: Roswell Park Cancer Institute)
- P30CA016056 (U.S. NIH Grant/Contract)
- NCI-2017-00441 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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