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

NCT01236443 | Completed Phase 1 DMC

• 1 other identifier: RP 00-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett's Esophagus; CIS; High Grade Dysplasia

Outcome Measures

Primary Outcomes (1)

• Toxicity of HPPH at different doses

  2 days

Secondary Outcomes (1)

• Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus

  length of study

Study Arms (1)

HPPH

EXPERIMENTAL

3 mg/m2

Drug: HPPH

Interventions

HPPH DRUG

3 mg/m2 IV

HPPH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park cancer institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hector Nava, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 8, 2010
• Study Start: August 1, 2000
• Primary Completion: May 1, 2003
• Study Completion: April 1, 2013
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (1)