Esophageal Cancer Clinical Trial
A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing
The purpose of this study is to establish the highest dose of laser light for WST-11 VTP to treat obstruction from esophageal cancer that can be safely given.
Age 18 or older
Confirmed tissue diagnosis of esophageal squamous cell cancer, adenocarcinoma or poorly differentiated carcinoma, with pathology reviewed at MSKCC
Has incurable disease defined as at least one of the following:
Presence of metastases to other organs (Stage IV), now or previously
Has locally advanced disease and are not candidates for surgery or more radiation treatment
Has received the maximal radiation therapy to the primary site, or has been assessed by radiation oncology as not being a candidate for chemoradiation therapy.
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) = 7 days prior to treatment
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 ≥8.5 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, or = 2.5 mg/dL for patients with a known history of Gilbert's syndrome
AST/ALT ≤5× upper limit of normal
Able to provide written informed consent
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
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There is 1 Location for this study
New York New York, 10021, United States
Reẖovot , , Israel
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