RECRUITING

NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer

Conditions

Borderline Resectable Pancreatic Adenocarcinoma Locally Advanced Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Ductal Adenocarcinoma Stage III Pancreatic Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To find the recommended dose of NBTXR3 that can be given in combination with radiation therapy to patients with pancreatic cancer. To learn if the dose NBTXR3 found in Part 1 can help to control the disease.

Official Title

Phase I Study of NBTXR3 Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Ductal Adenocarcinoma

Quick Facts

Study Start:2020-07-01

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04484909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study 2. Age ≥ 18 years 3. Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following: 1. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study 2. Age ≥ 18 years 3. Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following: 4. Has had a 4-month course (± 2-months) of chemotherapy for PDAC without radiographic evidence of distant metastatic disease. Following chemotherapy regimens are allowed: 1. gemcitabine/nab-paclitaxel 2. gemcitabine/capecitabine 3. gemcitabine/cisplatin 4. gemcitabine 5. FOLFOX 6. FOLFIRINOX 5. Amenable to undergo the endoscopic ultrasound guided injection of NBTXR3 as per investigator or treating physician. 6. Has a target lesion in the pancreas that is identifiable on cross sectional imaging by repeated measurements (via RECIST 1.1) at the same anatomical location 7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 8. Laboratory Values at screening: 1. Hemoglobin ≥ 8.0 g/dL 2. Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 3. Platelet Count ≥ 100,000/mm3 4. Creatinine ≤ 1.5 x upper limit of normal (ULN) 5. Total Bilirubin ≤ 2.0 mg/dL 6. AST / ALT ≤ 3.0 x upper limit of normal (ULN) 7. Serum albumin ≥ 3.0 g/dL 9. Negative pregnancy test ≤ 7 days prior to NBTXR3 injection in all females of child-bearing potential 10. If participant has a history of prior duodenal or biliar plastic stent, it should be replaced with a metal stent ≥ 1 week prior to Study Day 1.	1. Prior radiation therapy to the upper abdomen 2. Prior surgical resection of pancreatic tumor 3. Diagnosis other than pancreatic ductal adenocarcinoma. All other histologic types (i.e., adenosquamous, cystadenocarcinoma, etc.) are not eligible to participate on this study. 4. LAPC or BRPC with radiographic evidence of distant metastasis at screening. 5. Has received any approved or investigational anti-neoplastic agent other than the chemotherapies specified in this protocol (i.e. chemotherapies included in Inclusion #4) 6. Known uncontrolled (Grade ≥ 2) or active gastric or duodenal ulcer disease within 30 days of enrollment 7. Known contraindication to iodine-based or gadolinium-based IV contrast 8. Active malignancy, in addition to pancreatic cancer, with the exception of basal cell carcinoma of the skin definitively treated and relapse free within at least 1 year from diagnosis 9. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree atrioventricular heart block without a permanent pacemaker in place) 10. Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system \<6 months prior to screening 11. Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection 12. Female patients who are pregnant or breastfeeding 13. Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \< 1% per year when used consistently and correctly 14. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Inclusion Criteria

Exclusion Criteria

1. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study 2. Age ≥ 18 years 3. Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following:
1. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
2. Age ≥ 18 years
3. Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following:
4. Has had a 4-month course (± 2-months) of chemotherapy for PDAC without radiographic evidence of distant metastatic disease. Following chemotherapy regimens are allowed:
1. gemcitabine/nab-paclitaxel
2. gemcitabine/capecitabine
3. gemcitabine/cisplatin
4. gemcitabine
5. FOLFOX
6. FOLFIRINOX
5. Amenable to undergo the endoscopic ultrasound guided injection of NBTXR3 as per investigator or treating physician.
6. Has a target lesion in the pancreas that is identifiable on cross sectional imaging by repeated measurements (via RECIST 1.1) at the same anatomical location
7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
8. Laboratory Values at screening:
1. Hemoglobin ≥ 8.0 g/dL
2. Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
3. Platelet Count ≥ 100,000/mm3
4. Creatinine ≤ 1.5 x upper limit of normal (ULN)
5. Total Bilirubin ≤ 2.0 mg/dL
6. AST / ALT ≤ 3.0 x upper limit of normal (ULN)
7. Serum albumin ≥ 3.0 g/dL
9. Negative pregnancy test ≤ 7 days prior to NBTXR3 injection in all females of child-bearing potential
10. If participant has a history of prior duodenal or biliar plastic stent, it should be replaced with a metal stent ≥ 1 week prior to Study Day 1.

1. Prior radiation therapy to the upper abdomen
2. Prior surgical resection of pancreatic tumor
3. Diagnosis other than pancreatic ductal adenocarcinoma. All other histologic types (i.e., adenosquamous, cystadenocarcinoma, etc.) are not eligible to participate on this study.
4. LAPC or BRPC with radiographic evidence of distant metastasis at screening.
5. Has received any approved or investigational anti-neoplastic agent other than the chemotherapies specified in this protocol (i.e. chemotherapies included in Inclusion #4)
6. Known uncontrolled (Grade ≥ 2) or active gastric or duodenal ulcer disease within 30 days of enrollment
7. Known contraindication to iodine-based or gadolinium-based IV contrast
8. Active malignancy, in addition to pancreatic cancer, with the exception of basal cell carcinoma of the skin definitively treated and relapse free within at least 1 year from diagnosis
9. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree atrioventricular heart block without a permanent pacemaker in place)
10. Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system \<6 months prior to screening
11. Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection
12. Female patients who are pregnant or breastfeeding
13. Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \< 1% per year when used consistently and correctly
14. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Contacts and Locations

Study Contact

Eugene J Koay

CONTACT

713-563-2381

ekoay@mdanderson.org

Principal Investigator

Eugene J Koay

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Eugene J Koay, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-01

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-07-01

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Borderline Resectable Pancreatic Adenocarcinoma
Locally Advanced Pancreatic Ductal Adenocarcinoma
Resectable Pancreatic Ductal Adenocarcinoma
Stage III Pancreatic Cancer AJCC v8