Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
36

Inclusion Criteria

Previous esophageal dilation is permitted, provided the patient has developed recurrent dysphagia since that procedure
Calculated creatinine clearance ≥50 ml/min (using Cockcroft-Gault method)
Karnofsky performance status >/= 50%
...
Previous esophageal dilation is permitted, provided the patient has developed recurrent dysphagia since that procedure
Calculated creatinine clearance ≥50 ml/min (using Cockcroft-Gault method)
Karnofsky performance status >/= 50%
Age 18 or older
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.
Presence of metastases to other organs (Stage IV), now or previously
No endoluminal stent in place at the time of treatment
Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) </= 7 days prior to treatment
Total serum bilirubin ≤1.5 mg/dL, or </= 2.5 mg/dL for patients with a known history of Gilbert's syndrome
Platelets ≥75,000/ L
Has locally advanced disease and are not candidates for surgery or more radiation treatment
INR ≤1.5 (except for patients who are on full-dose warfarin)
Confirmed tissue diagnosis of esophageal squamous cell cancer, adenocarcinoma or poorly differentiated carcinoma, with pathology reviewed at MSKCC
Hb ≥8.5 g/dl
AST/ALT ≤5× upper limit of normal
ANC ≥1,000/ L
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)
Able to provide written informed consent
Prior radiation or surgery to the esophagus is permitted for patients with locally recurrent/persistent disease

Exclusion Criteria

Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/ml
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)
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
...
Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/ml
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)
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
Prior history of esophageal perforation
T4 tumors with involvement of any adjacent structure, including the trachea, aorta or pleura
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

Summary

Conditions
  • Esophagogastric Cancer
  • Moderate to Severe Dysphagia
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Previous esophageal dilation is permitted, provided the patient has developed recurrent dysphagia since that procedure
Calculated creatinine clearance ≥50 ml/min (using Cockcroft-Gault method)
Karnofsky performance status >/= 50%
...
Previous esophageal dilation is permitted, provided the patient has developed recurrent dysphagia since that procedure
Calculated creatinine clearance ≥50 ml/min (using Cockcroft-Gault method)
Karnofsky performance status >/= 50%
Age 18 or older
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.
Presence of metastases to other organs (Stage IV), now or previously
No endoluminal stent in place at the time of treatment
Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) </= 7 days prior to treatment
Total serum bilirubin ≤1.5 mg/dL, or </= 2.5 mg/dL for patients with a known history of Gilbert's syndrome
Platelets ≥75,000/ L
Has locally advanced disease and are not candidates for surgery or more radiation treatment
INR ≤1.5 (except for patients who are on full-dose warfarin)
Confirmed tissue diagnosis of esophageal squamous cell cancer, adenocarcinoma or poorly differentiated carcinoma, with pathology reviewed at MSKCC
Hb ≥8.5 g/dl
AST/ALT ≤5× upper limit of normal
ANC ≥1,000/ L
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)
Able to provide written informed consent
Prior radiation or surgery to the esophagus is permitted for patients with locally recurrent/persistent disease

Exclusion Criteria

Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/ml
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)
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
...
Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/ml
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)
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
Prior history of esophageal perforation
T4 tumors with involvement of any adjacent structure, including the trachea, aorta or pleura
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

Locations

New York, New York, 10021
Reẖovot
New York, New York, 10021
Reẖovot

Tracking Information

NCT #
NCT03133650
Collaborators
  • Weizmann Institute of Science
  • Steba Biotech S.A.
Investigators
  • Principal Investigator: Hans Gerdes, MD Memorial Sloan Kettering Cancer Center
  • Hans Gerdes, MD Memorial Sloan Kettering Cancer Center