Status:
COMPLETED
Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Esophageal Cancer
Precancerous Condition
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
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 ther...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00281736
Start Date
February 1 2004
End Date
December 1 2013
Last Update
January 3 2014
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001