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

This study has suspended participant recruitment.
(FDA clinical hold)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01140178
First received: June 7, 2010
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Dysplasia
Carcinoma of the Oral Cavity
Carcinoma of the Oropharynx
Drug: HPPH
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Tumor response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Amount of HPPH in the blood prior to light treatment. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Biomarkers, i.e. STAT3 crosslinks and/or activation status of pro-survival signaling molecules before and after PDT treatment. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: June 2010
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140178

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Hassan Arshad, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01140178     History of Changes
Other Study ID Numbers: I 170910
Study First Received: June 7, 2010
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
Photodynamic Therapy
Oral dysplasia
oral cavity carcinoma
oropharynx carcinoma.

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014