Vascular-Targeted Photodynamic Therapy with Padeliporfin in Treating Dysphagia in Patients with Stage IV Esophageal Cancer

Status: Active

Description

This phase I trial studies the side effects and best dose of vascular-targeted photodynamic therapy with padeliporfin in treating dysphagia in patients with stage IV esophageal cancer. Padeliporfin is a photosensitizing drug which stays in the blood vessels and becomes active when exposed to light. Vascular-targeted photodynamic therapy uses a laser to activate padeliporfin and may kill tumor cells and improve swallowing in patients with esophageal cancer.

Eligibility Criteria

Inclusion Criteria

  • Confirmed tissue diagnosis of esophageal squamous cell cancer, adenocarcinoma or poorly differentiated carcinoma, with pathology reviewed at Memorial Sloan-Kettering Cancer Center (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 dilatation 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
  • Absolute neutrophil count (ANC) >= 1,000/L, at baseline
  • Platelets >= 75,000/L, at baseline
  • Hemoglobin (Hg) >= 8.5 g/dl, at baseline
  • International normalized ratio (INR) =< 1.5 (except for patients who are on full-dose warfarin), at baseline
  • Calculated creatinine clearance >= 50 ml/min (using Cockcroft-Gault method), at baseline
  • Total serum bilirubin =< 1.5 mg/dl, or =< 2.5 mg/dl for patients with a known history of Gilbert's syndrome at baseline
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x upper limit of normal, at baseline
  • 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 mlU/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

Locations & Contacts

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Hans Gerdes
Phone: 212-639-7108

Trial Objectives and Outline

PRIMARY OBJECTIVE:

I. To determine the maximally tolerated laser light fluence rate (mW/cm) of light exposure for vascular-targeted photodynamic (VTP) treatment of malignant obstruction due to esophagogastric cancer (EGC), using a fixed dose of padeliporfin (WST11).

SECONDARY OBJECTIVES:

I. To assess the toxicities of VTP.

II. To assess the efficacy of VTP in relieving dysphagia.

III. To evaluate the histologic tissue response to VTP in the esophagus.

IV. To evaluate the immune response to VTP and effects on local and distant disease.

OUTLINE: This is a dose-escalation study of vascular-targeted photodynamic therapy.

Patients receive padeliporfin intravenously (IV) over 10 minutes and then undergo vascular-targeted photodynamic therapy over 20 minutes during upper endoscopy on day 0.

After completion of study treatment, patients are followed up for 60 days.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Hans Gerdes

Trial IDs

Primary ID 15-319
Secondary IDs NCI-2017-00897
Clinicaltrials.gov ID NCT03133650