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

NCT ID: NCT01238042

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2014-11-30

Brief Summary

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.

Conditions

Barrett's Esophagus; CIS; HGD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Light Dose Escalation

Light Dose escalated from 150 joules/cm to 200 joules/cm

Group Type: EXPERIMENTAL

HPPH

Intervention Type: DRUG

3mg/m2 or 4 mg/m2 at light doses of 150, 175 and 200 joules/cm

Interventions

HPPH

3mg/m2 or 4 mg/m2 at light doses of 150, 175 and 200 joules/cm

Intervention Type: DRUG

Eligibility 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 (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hector Nava, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RP 02-18

Identifier Type: -

Identifier Source: org_study_id