Photodynamic Therapy With HPPH in Treating Patients With Squamous Cell Carcinoma of the Oral Cavity

NCT ID: NCT02119728

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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.

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.

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 Lip and 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (standard of care surgery)

Patients undergo standard of care surgery on day 1.

Group Type: ACTIVE_COMPARATOR

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo standard of care surgery

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.

Group Type: EXPERIMENTAL

HPPH

Intervention Type: DRUG

Undergo photodynamic therapy with HPPH

Light Infusion Therapy™

Intervention Type: DEVICE

Undergo photodynamic therapy with HPPH

Interventions

HPPH

Undergo photodynamic therapy with HPPH

Intervention Type: DRUG

Light Infusion Therapy™

Undergo photodynamic therapy with HPPH

Intervention Type: DEVICE

therapeutic conventional surgery

Undergo standard of care surgery

Intervention Type: PROCEDURE

Other Intervention Names

Photochlor; PDT; therapy, photodynamic

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Arshad

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2014-00756

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 246513

Identifier Type: OTHER

Identifier Source: secondary_id

P01CA055791

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA016056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 246513

Identifier Type: -

Identifier Source: org_study_id