Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NCT Number: NCT01238042
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Buffalo, New York, 14263, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3mg/m2 or 4 mg/m2 at light doses of 150, 175 and 200 joules/cm
Time frame: 24 hours
Using toxicity to normal surrounding tissue as a determinant and using two HPPH doses of PDT in HGD, CIS or early adenocarcinoma in Barrett's esophagus, to determine the optimal light dose at each HPPH dose
Time frame: 24 hours
To determine the tocixity to normal surrounding tissue of treating at approximately 24 hours(21-26hr) post injection of HPPH
Time frame: 5 years
To determine the length of time of cutaneous photosensitivity of HPPH compared to historical data on Photofrin
Time frame: 24 hours
To determine the effect of a 24 hours interval between injection of HPPH and light treatment
Time frame: 5 years
A secondary objective is to determine efficacy of treatment at each set of paraments, i.e. ability to completely resolve the CIS, HGD or early cancer.
Time frame: 5 years
An Additional secondary objective is to determine ability of PDT to resolve the Barrett's mucosa
Roswell Park Cancer Institute
Other
A Pilot 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
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