Photodynamic Therapy for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byHans Gerdes, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with esophageal cancer that's inoperable or has spread to other organs. They should have a performance status indicating they can still carry out daily activities and must not have had recent systemic therapy. Adequate organ function is required, and women of childbearing potential must test negative for pregnancy and use contraception.

Inclusion Criteria

I've had esophageal dilation but my swallowing difficulties returned.

I haven't had any cancer treatments like chemotherapy or immunotherapy in the last week.

I am able to live at home and care for most of my personal needs.

+7 more

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.

Participant Groups

The study tests the highest safe dose of WST-11 VTP, a new photodynamic therapy using laser light to treat swallowing difficulties caused by esophageal cancer obstruction.

1Treatment groups

Experimental Treatment

Group I: Vascular-targeted photodynamic therapy (VTP) using WST11Experimental Treatment1 Intervention

Participants will receive intravenous administration of WST11 at a dose of 4 mg/kg, infused over 10 minutes, during an endoscopy procedure, followed by immediate laser light application.