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

NCT03090412 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: I 33616NCI-2017-00441P30CA016056
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stage I Oral Cavity Squamous Cell Carcinoma; Stage II Oral Cavity Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Quality of Life as Measured by the University of Washington Quality of Life Questionnaire Version 4

  Baseline up to 24 months

• Adverse Events as Graded by CTCAE Version 4.0 Are Reported

  Up to 30 days after administration of HPPH

Study Arms (2)

Arm I (surgery)

EXPERIMENTAL

Patients undergo standard of care surgery on day 1.

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.

Drug: HPPH; Other: Laboratory Biomarker Analysis; Drug: Photodynamic Therapy; Other: Quality-of-Life Assessment

Interventions

HPPH DRUG

Given IV

Also known as: Photochlor

Arm II (HPPH, PDT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm II (HPPH, PDT)

Photodynamic Therapy DRUG

Undergo PDT

Also known as: PDT, Photoradiation Therapy

Arm II (HPPH, PDT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (surgery); Arm II (HPPH, PDT)

Therapeutic Conventional Surgery PROCEDURE

Undergo standard of care surgery

Arm I (surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of Rocherster

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Phototherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Results Point of Contact

• Title: Katy Wang
• Organization: Roswell Park Comprehensive Cancer Center

Chong.Wang@roswellpark.org

716-845-6269

Study Officials

• Jon Chan

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: March 20, 2017
• First Posted: March 24, 2017
• Study Start: March 7, 2018
• Primary Completion: August 1, 2021
• Study Completion: August 6, 2021
• Last Updated: June 2, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-05

Locations

US (2)