Clinical trial · Interventional
Study of Photodynamic Therapy (PDT) Using HPPH in Barrett's Esophagus
A Phase I/II Study of Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2-devinylpyropheophorbide-a (HPPH) for the Treatment of High Grade Dysplasia, Carcinoma-in-situ and Early Adenocarcinoma in Barrett's Esophagus
NCT01236443CI-TRIAL-00013434completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Study to identify toxicity and optimal photodynamic treatment parameters using the photosensitizer 2-\[1-hydroxyethyl\]-2-devinylpyropheophorbide-a (HPPH) in high grade dysplasia, carcinoma-in-situ, or early adenocarcinoma in Barrett's esophagus.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| CIS | Carcinoma In Situ | ALIAS | 0.90 |
| High Grade Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPPH | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPPH
- description
- 3 mg/m2
- interventionNames
- Drug: HPPH
Primary outcomes (1)
- measure
- Toxicity of HPPH at different doses
- timeFrame
- 2 days
Secondary outcomes (1)
- measure
- Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus
- timeFrame
- length of study
- description
- Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 can be primary or recurrent, Stage 0 or I, N0M (any). * Patients must have no contraindications 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. * Operable patients are not excluded. Exclusion Criteria: * Patients with tumors of grade greater than T-1. * Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds. * WBC \<2,000; platelet count \<50,000, prothrombin time 1.5 times above the 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. * If the patient has cancer other than non-melanoma skin cancer they must be deemed disease free by their treating physician.
References
Publications (0)
Data not yet available
No reference posted for this study.