Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer
A Phase II Study of HPPH Photodynamic Therapy for Treatment of High Grade Dysplasia, Carcinoma In-Situ or Early Intramucosal Adenocarcinoma in Barrett's Esophagus. Randomization to Two PDT Treatment Regimens of HPPH (2-1 [Hexyloxyethyl]-2devinylpyropheophorbide-a) and Light
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light, and kills tumor cells. HPPH may be effective in killing precancerous cells and tumor cells.
PURPOSE: This randomized phase II trial is studying how well photodynamic therapy with HPPH works in treating patients with precancerous esophageal conditions or stage 0 or stage I esophageal cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine response in patients with high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus and Barrett's esophagus treated with photodynamic therapy using HPPH.
- Determine the safety, in terms of toxicity to surrounding normal tissue, of this regimen in these patients.
- Determine the toxic effects of this regimen on surrounding normal tissue in these patients.
- Determine the incidence of adenocarcinoma in these patients after this treatment.
- Determine the magnitude and duration of increased skin sun sensitivity in patients treated with this regimen.
- Determine the minimal erythemal dose of this regimen in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to presence of intramucosal tumor (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
- Arm II: Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study within 3 years.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus
- Stage 0 or N0, M0 primary or recurrent disease
- Diagnosis of Barrett's esophagus
- Ineligible for or refused surgical resection
- Requires endoscopy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 50-100%
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 4,000/mm^3
- Platelet count ≥ 100,000/mm^3
- PT ≤ 1.5 times upper limit of normal (ULN)
Hepatic
- Bilirubin ≤ 2.0 mg/dL
- Alkaline phosphatase ≤ 3 times ULN
- ALT ≤ 3 times ULN
Renal
- Creatinine ≤ 2 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No contraindication to endoscopy
- No other malignancy except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free
- No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
PRIOR CONCURRENT THERAPY:
Chemotherapy
- At least 1 month since prior chemotherapy
- No concurrent chemotherapy
Radiotherapy
- At least 1 month since prior radiotherapy
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 1 month since prior Nd-YAG laser therapy
- At least 4 weeks since prior therapy for this disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I
Patients receive HPPH IV over 1 hour on day 1.
Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
|
Given IV
|
|
Experimental: Arm II
Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.
|
Given IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Efficacy
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Response
Time Frame: 3 years
|
3 years
|
|
Toxicity
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hector R. Nava, MD, FACS, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000441205
- I 30404 (Other Identifier: Roswell Park Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.