- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02119728
Photodynamic Therapy With HPPH in Treating Patients With Squamous Cell Carcinoma of the Oral Cavity
A Randomized Multicenter Phase II Study Using HPPH With PDT Versus Standard of Care Surgery for Patients With T1/T2 Squamous Cell Carcinoma of the Oral Cavity
Study Overview
Status
Conditions
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Oropharynx
- Recurrent Verrucous Carcinoma of the Oral Cavity
- Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage I Squamous Cell Carcinoma of the Oropharynx
- Stage I Verrucous Carcinoma of the Oral Cavity
- Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage II Squamous Cell Carcinoma of the Oropharynx
- Stage II Verrucous Carcinoma of the Oral Cavity
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Squamous Cell Carcinoma of the Oropharynx
- Stage III Verrucous Carcinoma of the Oral Cavity
- Stage IVA Squamous Cell Carcinoma of the Oropharynx
- Stage IVA Verrucous Carcinoma of the Oral Cavity
- Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVB Squamous Cell Carcinoma of the Oropharynx
- Stage IVB Verrucous Carcinoma of the Oral Cavity
- Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVC Squamous Cell Carcinoma of the Oropharynx
- Stage IVC Verrucous Carcinoma of the Oral Cavity
- Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery.
SECONDARY OBJECTIVES:
I. To determine improvement in quality of life (QoL) using the University of Washington Quality of life questionnaire version 4.
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).
III. To explore progression-free survival in this patient population treated with HPPH mediated PDT.
TERTIARY OBJECTIVES:
I. Immune markers (T cells). II. To investigate the correlation of the tri-modal optical spectroscopy with tumor response to PDT.
OUTLINE: Patients are randomized to 1 of 2 treatments 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. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.
After completion of study treatment, patients are followed up 3-4 months for 1 year, 3-6 months for 1 year, 4-8 months for 1 year, and once a year for 2 years.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
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
- Patients with Tl/T2 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 (in the judgment of the physician)
- Computed tomography (CT) 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
- Patients 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 or her partner is participating in this study, she should inform her treating physician immediately
- Patient 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:
- Patients 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
- Patients with known brain metastases should be excluded from this clinical trial
- Patients 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) > 3 times the upper normal limit
- Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
- 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 female patients
- 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
- Received an investigational agent within 30 days prior to enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Arm I (standard of care surgery)
Patients undergo standard of care surgery on day 1.
|
Undergo standard of care surgery
|
EXPERIMENTAL: Arm II (HPPH, photodynamic therapy)
Patients receive HPPH IV over 1 hour on day 0. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.
|
Undergo photodynamic therapy with HPPH
Other Names:
Undergo photodynamic therapy with HPPH
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumors version 1.1
Time Frame: 3 months after treatment
|
Objective tumor response will be tabulated overall.
Tumor response will be determined by comparing photographs of the treated site (with reference ruler) before and after PDT.
Efficacy (e.g., tumor response) will be estimated using simple relative frequencies.
The corresponding 95% confidence intervals for the estimated probabilities will be computed using the method proposed in Clopper and Pearson.
|
3 months after treatment
|
Changes in quality of life evaluated by the University of Washington Quality of Life Questionnaire version 4
Time Frame: Baseline to up to 5 years
|
In the analysis of QoL simple data analyses will initially take place including individual patient 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.
All tests will be two-sided and tested at a 0.05 nominal significance level.
Standard diagnostic plots will be used to assess model fit and transformations of variables may be considered in order to meet statistical assumptions.
|
Baseline to up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of toxicity graded according to NCI CTCAE version 4.0
Time Frame: Up to 6 weeks after treatment
|
The frequency of toxicities will be tabulated by grade across all cycles.
The safety of the interventions will be assessed through the evaluation of grade 3 or higher toxicities deemed possibly related to treatment.
Toxicity rates will be estimated using simple relative frequencies.
The corresponding 95% confidence intervals for the estimated probabilities will be computed using the method proposed in Clopper and Pearson.
|
Up to 6 weeks after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hassan Arshad, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Neoplasms, Squamous Cell
- Carcinoma
- Recurrence
- Carcinoma, Squamous Cell
- Oropharyngeal Neoplasms
- Carcinoma, Verrucous
Other Study ID Numbers
- I 246513 (OTHER: Roswell Park Cancer Institute)
- P30CA016056 (U.S. NIH Grant/Contract)
- P01CA055791 (U.S. NIH Grant/Contract)
- NCI-2014-00756 (REGISTRY: CTRP (Clinical Trial Reporting Program))
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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