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
18 Years
N/A
Both
Esophageal Cancer, Precancerous Condition
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Hector R. Nava, MD, FACS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000441205
NCT ID:
NCT00281736
Start Date:
February 2004
Completion Date:
Related Keywords:
- Esophageal Cancer
- Precancerous Condition
- adenocarcinoma of the esophagus
- recurrent esophageal cancer
- stage 0 esophageal cancer
- stage I esophageal cancer
- precancerous condition
- Adenocarcinoma
- Esophageal Diseases
- Esophageal Neoplasms
- Precancerous Conditions
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
