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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Barrett's Esophagus, CIS, High Grade Dysplasia

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity of HPPH at different doses

Outcome Time Frame:

2 days

Safety Issue:

Yes

Principal Investigator

Hector Nava, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

RP 00-02

NCT ID:

NCT01236443

Start Date:

August 2000

Completion Date:

April 2013

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263