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

Sponsor

Roswell Park Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01236443

Collaborator

(none)

Enrollment

Location

Arm

152

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus CIS High Grade Dysplasia	Drug: HPPH	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2000

Actual Primary Completion Date :

May 1, 2003

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HPPH 3 mg/m2	Drug: HPPH 3 mg/m2 IV

Arm

Intervention/Treatment

Experimental: HPPH

3 mg/m2

Drug: HPPH

3 mg/m2 IV

Outcome Measures

Primary Outcome Measures

Toxicity of HPPH at different doses [2 days]

Secondary Outcome Measures

Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus [length of study]
Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park cancer institute	Buffalo	New York	United States	14263

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Principal Investigator: Hector Nava, MD, Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roswell Park Cancer Institute

ClinicalTrials.gov Identifier:

NCT01236443

Other Study ID Numbers:

RP 00-02

First Posted:

Nov 8, 2010

Last Update Posted:

Jan 13, 2014

Last Verified:

Jan 1, 2014

Additional relevant MeSH terms:

Barrett Esophagus

Study Results

No Results Posted as of Jan 13, 2014