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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light Dose Escalation | Experimental | Light Dose escalated from 150 joules/cm to 200 joules/cm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPPH | Drug | 3mg/m2 or 4 mg/m2 at light doses of 150, 175 and 200 joules/cm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Optimal Light Dose | 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 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity to normal surrounding tissue | To determine the tocixity to normal surrounding tissue of treating at approximately 24 hours(21-26hr) post injection of HPPH | 24 hours |
| Comparing HPPH to Photofrin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hector Nava, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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To determine the length of time of cutaneous photosensitivity of HPPH compared to historical data on Photofrin
| 5 years |
| Effect of injection | To determine the effect of a 24 hours interval between injection of HPPH and light treatment | 24 hours |
| Efficacy of Treatment | 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. | 5 years |
| Resolve Barrett's mucosa | An Additional secondary objective is to determine ability of PDT to resolve the Barrett's mucosa | 5 years |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C083998 | 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a |
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