A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing

Inclusion Criteria:

- Age 18 or older

- Confirmed tissue diagnosis of esophageal squamous cell cancer, adenocarcinoma or
poorly differentiated carcinoma, with pathology reviewed at MSKCC

- Incurable disease defined by the presence of metastases beyond regional lymph nodes

- Dysphagia grade 3 due to tumor obstruction

- Karnofsky performance status >/= 50%

- No endoluminal stent in place at the time of treatment

- Previous esophageal dilation is permitted, provided the patient has developed
recurrent dysphagia since that procedure

- Patients should not have received any systemic therapy (including chemotherapy,
biologic therapy or immunotherapy)
- Prior radiation or surgery to the esophagus is permitted for patients with locally
recurrent/persistent disease

- Patients on prophylactic or full-dose anticoagulation are eligible, provided the
treating physician believes it is safe to temporarily withhold anticoagulation (see
Section 9.2)

- Adequate organ function defined at baseline as:

- ANC ≥1,000/ L

- Platelets ≥75,000/ L

- Hb ≥9 g/dl

- INR ≤1.5 (except for patients who are on full-dose warfarin)

- Calculated creatinine clearance ≥50 ml/min (using Cockcroft-Gault method)

- Total serum bilirubin ≤1.5 mg/dL

- AST/ALT ≤5× upper limit of normal

- Able to provide written informed consent

Exclusion Criteria:

- Pregnant or breast-feeding women. Women of childbearing potential (WOCBP) must undergo
a negative pregnancy test (either serum or urine) prior to study entry. Both sexes
must use contraception while on study. WOCBP include:

- Any woman who has experienced menarche and who has not undergone surgical
sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is
not post-menopausal (defined as amenorrheic ≥12 consecutive months)

- Women on hormone replacement therapy with documented serum follicle stimulating
hormone level > 35 mIU/ml

- Women who are using oral, implanted or injectable contraceptive hormones or
mechanical products such as intrauterine device or barrier methods to prevent
pregnancy or are practicing abstinence of where the partner is sterile

- T4 tumors with involvement of any adjacent structure, including the trachea, aorta or
pleura

- Prior history of esophageal perforation

- Any other medical or psychiatric comorbidities, including decompensated heart failure,
unstable angina or coronary artery disease or severe pulmonary disease, that, in the
opinion of the study investigator, would make the patient a poor candidate for the
study