Back to resultsA Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx
Primary Purpose
Dysplasia, Carcinoma of the Oral Cavity, Carcinoma of the Oropharynx
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HPPH
Sponsored by
About this trial
This is an interventional treatment trial for Dysplasia focused on measuring Photodynamic Therapy, Oral dysplasia, oral cavity carcinoma, oropharynx carcinoma.
Eligibility 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.
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HPPH
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Tumor response
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.
Amount of HPPH in the blood prior to light treatment.
Biomarkers, i.e. STAT3 crosslinks and/or activation status of pro-survival signaling molecules before and after PDT treatment.
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
Full Information
NCT ID
NCT01140178
First Posted
June 7, 2010
Last Updated
October 15, 2018
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01140178
Brief Title
A Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 8, 2010 (Actual)
Primary Completion Date
January 29, 2013 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysplasia, Carcinoma of the Oral Cavity, Carcinoma of the Oropharynx
Keywords
Photodynamic Therapy, Oral dysplasia, oral cavity carcinoma, oropharynx carcinoma.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPPH
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
HPPH
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Toxicity
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Tumor response
Time Frame
3 months
Title
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
Title
Amount of HPPH in the blood prior to light treatment.
Time Frame
3 months
Title
Biomarkers, i.e. STAT3 crosslinks and/or activation status of pro-survival signaling molecules before and after PDT treatment.
Time Frame
3 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Arshad, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx
We'll reach out to this number within 24 hrs