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

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 1

Conditions

CIS

HGD

Barrett's Esophagus

Treatments

Drug: HPPH

Study type

Interventional

Funder types

Other

Identifiers

NCT01238042

RP 02-18

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.