A Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx

A Phase la Trial of Photodynamic Therapy With HPPH (2-1 (Hexyloxyethyl)-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx.

Recent literature suggests that certain patients with squamous cell cancers of the head and neck region may benefit from photodynamic therapy whether or not they may have received prior therapy, e.g. radiation therapy

Study Overview

• Status: Completed
• Conditions: Dysplasia; Carcinoma of the Oral Cavity; Carcinoma of the Oropharynx
• Intervention / Treatment: Drug: HPPH

Detailed Description

We propose to initiate a Phase 1 a clinical trial using HPPH and 665 nm light in patients with cancer of the oral cavity and/or oropharynx, including lesions of moderate to severe dysplasia, squamous carcinoma in situ and T1 squamous cells carcinoma. The study will employ a fixed HPPH dose of 4 mg/m2 infused over 1 hour, and 24 hours later light doses escalating from 100 J/cm2 to 125 and 140 J/cm2, respectively. The primary goal is the determination of the maximally tolerated PDT dose. Preliminary evidence for PDT efficacy wil also be obtained.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with moderate to severe dysplasia and/or squamous carcinoma-in-situ of the oral cavity and/or oropharynx.
• Patients with T1 squamous cell carcinoma of the oral cavity and/or oropharynx.
• Patient may have primary and/or recurrent lesions to be treated.
• Diagnosis must confirmed by biopsy.
• Prior therapy of any type is allowed.
• Male or female patients at least 18 years old. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal. Male patients should be using a medically acceptable form of birth control or be sterile.
• Patients must have an ECOG score of 0-2 (Appendix A 1 ).
• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

• Patients with T2 or greater squamous cell carcinoma.
• True tongue base lesions (as determined by the treating physician).
• Patients with severe trismus that prevents adequate access to the lesion for treatment light delivery (as determined by the treating physician).
• Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
• Patients with impaired hepatic (alkaline phosphatase (hepatic) or SGOT;:3 times the upper normal limits).
• Patients with minimal impairment of renal function (total serum bilirubin;: 2 mg/dl, serum creatinine;: 2 mg/dl)
• 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 and or light treatment.
• Patients on concurrent chemotherapy or radiation therapy or less than 4 weeks after the last dose of chemotherapy or radiation therapy.

Inclusion of Women and Minorities:

• Both men and women and members of all races and ethnic groups are eligible for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPPH; a fixed HPPH dose of 4 mg/m2 infused over 1 hour, and 24 hours later light doses escalating from 100 J/cm2 to 125 and 140 J/cm2, respectively.	Drug: HPPH; Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity	To determine the maximally tolerated dose in the oral cavity and/or oropharynx of photodynamic therapy (PDT) using HPPH (2-1 (hexyloxyethyl)-2- devinylpyropheophorbide-a) and 665 nm light.	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumor response	3 months
Response of dysplasia, CiS and selected patients with T1 squamous cell carcinoma of the oral cavity and/or oropharynx using photodynamic therapy (PDT) with HPPH (2-1 (hexyloxyethyl)-2-devinylpyropheophorbide-a) and 665 nm light.	3 months
Amount of HPPH in the blood prior to light treatment.	3 months
Biomarkers, i.e. STAT3 crosslinks and/or activation status of pro-survival signaling molecules before and after PDT treatment.	3 months
To determine non-invasively HPPH fluorescence and blood flow in To determine non-invasively HPPH fluorescence and blood flow in tumor and surrounding normal tissue before and after PDT	3 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2010
• Primary Completion (Actual): January 29, 2013
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: June 7, 2010
• First Submitted That Met QC Criteria: June 8, 2010
• First Posted (Estimate): June 9, 2010

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Photodynamic Therapy; Oral dysplasia; oral cavity carcinoma; oropharynx carcinoma.
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Carcinoma; Hyperplasia
• Other Study ID Numbers: I 170910