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Procedure

Photodynamic Therapy for Esophageal Cancer

Phase 1

Waitlist Available

Led By Hans Gerdes, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) </= 7 days prior to treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment to see what the highest safe dose is.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions to photodynamic therapies such as tissue inflammation, discomfort at the treatment site, photosensitivity reactions, or changes in blood parameters due to organ response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 18 years old or older.

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My esophageal cancer diagnosis has been confirmed and reviewed.

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My disease cannot be cured and has spread or cannot be treated with surgery or more radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated laser fluence rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met