Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer

Stage I Oral Cavity Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03090412
• Other study ID #: I 33616
• Secondary ID: NCI-2017-00441I
• Status: Terminated
• Phase: Phase 2
• Start date: March 7, 2018
• Est. completion date: August 6, 2021

Study information

• Verified date: May 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 in treating patients with oral cavity cancer.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 6, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Stage I Oral Cavity Squamous Cell Carcinoma
• Stage II Oral Cavity Squamous Cell Carcinoma

Intervention

Drug:
• HPPH
Given IV

Other:
• Laboratory Biomarker Analysis
Correlative studies

Drug:
• Photodynamic Therapy
Undergo PDT

Other:
• Quality-of-Life Assessment
Ancillary studies

Procedure:
• Therapeutic Conventional Surgery
Undergo standard of care surgery

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of Rocherster	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1	Objective tumor response will be tabulated overall.	At 24 months
Secondary	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	Baseline up to 24 months
Secondary	Adverse Events as Graded by CTCAE Version 4.0 Are Reported	The frequency of toxicities will be tabulated by grade.	Up to 30 days after administration of HPPH