RECRUITING

NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer

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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

The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.

Official Title

A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus

Quick Facts

Study Start:2020-11-23

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04615013

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
* Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction * Adenocarcinoma of the esophagus stages II-III allowed * Medically able to receive chemoradiation. Following chemotherapy regimens are allowed: * Oxaliplatin and fluorouracil (5-FU) or capecitabine * Docetaxel and/or 5-FU or paclitaxel * Carboplatin and paclitaxel * Amenable to undergo the endoscopic ultrasound (EUS) guided injection of NBTXR3 as determined by the investigator or treating physician * Patients with lesions for which the EUS scope is not able to traverse the tumor are allowed on this trial as long as an injection can be performed as per treating physician's discretion * Has at least 1 and up to 4 target lesion(s) in the esophagus that are measurable on cross sectional imaging and repeated measurements (via Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) at the same anatomical location should be achievable * Local nodal disease around the esophagus allowed * Nodal target lesions must be \>= 15 mm (short axis) based on computed tomography (CT) (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Hemoglobin \>= 8.0 g/dL * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Creatinine =\< 1.5 x upper limit of normal (ULN) * Calculated (Calc.) creatinine clearance \> 30 mL/min * Glomerular filtration ratio \> 40 mL/min per 1.73 m\^2 * Total bilirubin =\< 2.0 mg/dL * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * Negative urine or serum pregnancy test =\< 7 days of NBTXR3 injection in all female participants of child-bearing potential * 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	* Prior radiation or any therapy for the treatment of esophageal cancer * Prior surgical resection of esophageal tumor * Esophageal cancer with radiographic evidence of metastases at screening * At screening, past medical history of: * Esophageal fistula * Tracheoesophageal fistula * Siewert type III tumors * Evidence of bulky disease and/or abutment of tumor above the carina that may result in tracheoesophageal fistulas as determined by the investigator or treating physician * Tumors above the carina without defacement of the fat plane between tumor and the airway are allowed * Known uncontrolled (grade \>= 2) or active esophageal or gastric ulcer disease within 28 days of enrollment * Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast * Active malignancy, in addition to esophageal cancer except for basal cell carcinoma of the skin or non-metastatic low risk prostate cancer definitively treated and relapse free within at least 3 months from time of screening * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment * Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection * Female patients who are pregnant or breastfeeding * Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy 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 * 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

* Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction
* Adenocarcinoma of the esophagus stages II-III allowed
* Medically able to receive chemoradiation. Following chemotherapy regimens are allowed:
* Oxaliplatin and fluorouracil (5-FU) or capecitabine
* Docetaxel and/or 5-FU or paclitaxel
* Carboplatin and paclitaxel
* Amenable to undergo the endoscopic ultrasound (EUS) guided injection of NBTXR3 as determined by the investigator or treating physician
* Patients with lesions for which the EUS scope is not able to traverse the tumor are allowed on this trial as long as an injection can be performed as per treating physician's discretion
* Has at least 1 and up to 4 target lesion(s) in the esophagus that are measurable on cross sectional imaging and repeated measurements (via Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) at the same anatomical location should be achievable
* Local nodal disease around the esophagus allowed
* Nodal target lesions must be \>= 15 mm (short axis) based on computed tomography (CT) (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Hemoglobin \>= 8.0 g/dL
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Creatinine =\< 1.5 x upper limit of normal (ULN)
* Calculated (Calc.) creatinine clearance \> 30 mL/min
* Glomerular filtration ratio \> 40 mL/min per 1.73 m\^2
* Total bilirubin =\< 2.0 mg/dL
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
* Negative urine or serum pregnancy test =\< 7 days of NBTXR3 injection in all female participants of child-bearing potential
* 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

* Prior radiation or any therapy for the treatment of esophageal cancer
* Prior surgical resection of esophageal tumor
* Esophageal cancer with radiographic evidence of metastases at screening
* At screening, past medical history of:
* Esophageal fistula
* Tracheoesophageal fistula
* Siewert type III tumors
* Evidence of bulky disease and/or abutment of tumor above the carina that may result in tracheoesophageal fistulas as determined by the investigator or treating physician
* Tumors above the carina without defacement of the fat plane between tumor and the airway are allowed
* Known uncontrolled (grade \>= 2) or active esophageal or gastric ulcer disease within 28 days of enrollment
* Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast
* Active malignancy, in addition to esophageal cancer except for basal cell carcinoma of the skin or non-metastatic low risk prostate cancer definitively treated and relapse free within at least 3 months from time of screening
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment
* Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
* Female patients who are pregnant or breastfeeding
* Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy 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
* 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

Principal Investigator

Steven H Lin

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

Steven H Lin, 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 Date2020-11-23

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2020-11-23

Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

Cervical Esophagus Adenocarcinoma
Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Gastroesophageal Junction Adenocarcinoma
Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
Thoracic Esophagus Adenocarcinoma