Status:
COMPLETED
Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or Early Adenocarcinoma In Barrett's Esophagus
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Barrett's Esophagus
CIS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Patient's with High Grade Dysplasia, Carcinoma in situ or Early Adenocarcinoma in Barrett's Esophagus are injected with HPPH and one day later are endoscopically treated with light from a laser.
Eligibility Criteria
Inclusion
- Patient must have biopsy proven high-grade (severe)dysplasia, carcinoma-in-situ or early stage adenocarcinoma
- Patient may have received prior therapy; e.g.Nd-YAG laser, radiation therapy or chemotherapy. At least one-month must have elapsed between prior treatments and PDT
- Tumors (HGD/CIS or early adenocarcinoma) can be primary or recurrent, Stage 0 or I N0M (any)
- Patients must have no contraindication to endoscopy
- Male or female patients must be 18 years old or older. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control or be sterile or post-menopausal. A Pregnancy test is required and must be negative.
- Patients must sign an Informed Consent according to FDA guidelines and be acceptable to the RPCI IRB
- Patients must have a Karnofsky status 50 or above.
- Patients with early invasive adenocarcinoma will be included only if they are considered poor surgical risks, have failed or refused XRT/chemo, or refused surgery.
- If the patients has had cancer other than non-melanoma skin cancer, their treating physician must deem them disease-free.
Exclusion
- Patients with tumors of grade greater than T-1.
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
- WBC\<4000; platelet count\<100,000; prothrombin times 1.5 times above upper normal limit.
- Patients with impaired renal and/or hepatic function (total serum bilirubin \> 3.0 mg/d, serum creatinine\>3 mg%, alkaline phosphatase (hepatic) or SGOT\> 3 times the upper normal limit.
- Patients on concurrent chemotherapy or radiation therapy will be excluded as well as those having received prior treatment for the esophageal cancer within 4 weeks of enrollment.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01238042
Start Date
March 1 2003
End Date
November 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263