Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or Early Adenocarcinoma In Barrett's Esophagus

A Pilot Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or Early Adenocarcinoma In Barrett's Esophagus

Patient's with High Grade Dysplasia, Carcinoma in situ or Early Adenocarcinoma in Barrett's Esophagus are injected with HPPH and one day later are endoscopically treated with light from a laser.

Study Overview

• Status: Completed
• Conditions: Barrett's Esophagus; CIS; HGD
• Intervention / Treatment: Drug: HPPH

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 (HGD/CIS or early adenocarcinoma) can be primary or recurrent, Stage 0 or I N0M (any)
• Patients must have no contraindication 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.
• Patients with early invasive adenocarcinoma will be included only if they are considered poor surgical risks, have failed or refused XRT/chemo, or refused surgery.
• If the patients has had cancer other than non-melanoma skin cancer, their treating physician must deem them disease-free.

Exclusion Criteria:

• Patients with tumors of grade greater than T-1.
• Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
• WBC<4000; platelet count<100,000; prothrombin times 1.5 times above 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light Dose Escalation; Light Dose escalated from 150 joules/cm to 200 joules/cm	Drug: HPPH; 3mg/m2 or 4 mg/m2 at light doses of 150, 175 and 200 joules/cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal Light Dose	Using toxicity to normal surrounding tissue as a determinant and using two HPPH doses of PDT in HGD, CIS or early adenocarcinoma in Barrett's esophagus, to determine the optimal light dose at each HPPH dose	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity to normal surrounding tissue	To determine the tocixity to normal surrounding tissue of treating at approximately 24 hours(21-26hr) post injection of HPPH	24 hours
Comparing HPPH to Photofrin	To determine the length of time of cutaneous photosensitivity of HPPH compared to historical data on Photofrin	5 years
Effect of injection	To determine the effect of a 24 hours interval between injection of HPPH and light treatment	24 hours
Efficacy of Treatment	A secondary objective is to determine efficacy of treatment at each set of paraments, i.e. ability to completely resolve the CIS, HGD or early cancer.	5 years
Resolve Barrett's mucosa	An Additional secondary objective is to determine ability of PDT to resolve the Barrett's mucosa	5 years

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Hector Nava, MD, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 1, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 10, 2010

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Adenocarcinoma; Barrett Esophagus
• Other Study ID Numbers: RP 02-18