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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01236443
First received: November 2, 2010
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Barrett's Esophagus
CIS
High Grade Dysplasia
Drug: HPPH
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Toxicity of HPPH at different doses [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus [ Time Frame: length of study ] [ Designated as safety issue: No ]
    Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus


Enrollment: 18
Study Start Date: August 2000
Study Completion Date: April 2013
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPPH
3 mg/m2
Drug: HPPH
3 mg/m2 IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236443

Locations
United States, New York
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
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01236443     History of Changes
Other Study ID Numbers: RP 00-02
Study First Received: November 2, 2010
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 24, 2014