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
4 other identifiers
interventional
N/A
1 country
1
Brief Summary
This randomized phase II trial studies how well photodynamic therapy with HPPH works in treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses HPPH that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against squamous cell carcinoma of the oral cavity.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedApril 21, 2016
April 1, 2016
April 17, 2014
April 19, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumors version 1.1
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
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 Outcomes (1)
Frequency of toxicity graded according to NCI CTCAE version 4.0
Up to 6 weeks after treatment
Study Arms (2)
Arm I (standard of care surgery)
ACTIVE COMPARATORPatients undergo standard of care surgery on day 1.
Arm II (HPPH, photodynamic therapy)
EXPERIMENTALPatients receive HPPH IV over 1 hour on day 0. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.
Interventions
Undergo photodynamic therapy with HPPH
Undergo photodynamic therapy with HPPH
Undergo standard of care surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roswell Park Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hassan Arshad
Roswell Park Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2014
First Posted
April 22, 2014
Primary Completion
January 1, 2017
Last Updated
April 21, 2016
Record last verified: 2016-04