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

NCT01140178 | Completed Phase 1 DMC

• 1 other identifier: I 170910
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysplasia; Carcinoma of the Oral Cavity; Carcinoma of the Oropharynx

Keywords

Photodynamic Therapy; Oral dysplasia; oral cavity carcinoma; oropharynx carcinoma.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

HPPH

EXPERIMENTAL

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

Interventions

HPPH DRUG

Given IV

HPPH

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Hassan Arshad, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: June 8, 2010
• Primary Completion: January 29, 2013
• Study Completion: October 1, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

US (1)