Study of Photodynamic Therapy (PDT) Using HPPH in Barrett's Esophagus

Barrett's Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236443
• Other study ID #: RP 00-02
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2010
• Last updated: January 10, 2014
• Start date: August 2000
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2013
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• CIS
• High Grade Dysplasia

Intervention

Drug:
• HPPH
3 mg/m2 IV

Locations

Country	Name	City	State
United States	Roswell Park cancer institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity of HPPH at different doses		2 days	Yes
Secondary	Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus	Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus	length of study	No