Clinical trial NCT03133650: A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing
Official title: A Phase I Trial of Vascular-Targeted Photodynamic Therapy in Esophagogastric Cancer Patients With Moderate to Severe Dysphagia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Esophagogastric Cancer
Moderate to Severe Dysphagia
Keywords: Vascular-Targeted Photodynamic Therapy (VTP)
15-319
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weizmann Institute of Science
name: Steba Biotech S.A.
First posted: 2017-04-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Maximum tolerated laser fluence rate
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center (Data Analysis Only)
state: New York
city: Reẖovot
country: Israel
facility: Weizmann Institute of Science
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Hans Gerdes, MD
role: PRINCIPAL_INVESTIGATOR
References: