Using NBTXR3 with chemotherapy and radiation to treat esophageal cancer
A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus
This study is testing a new drug called NBTXR3, combined with chemotherapy and radiation, to see if it can safely help people with esophageal cancer who haven't been treated before.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04615013 on ClinicalTrials.gov |
What this trial studies
This Phase I study aims to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3, a drug activated by radiation therapy, in combination with concurrent chemotherapy for patients with esophageal adenocarcinoma. The study involves administering NBTXR3 intratumorally or intranodally, followed by intensity-modulated radiation therapy (IMRT) and chemotherapy regimens. The primary focus is on evaluating the safety, feasibility, and anti-tumor response of this combination treatment in treatment-naive patients. Additionally, the study will explore various outcomes, including surgical results and immune-related biomarkers.
Who should consider this trial
Good fit: Ideal candidates include patients with biopsy-proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction, specifically those with stages II-III disease.
Not a fit: Patients with esophageal adenocarcinoma that is not amenable to endoscopic ultrasound-guided injection or those with unresectable disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with esophageal adenocarcinoma, potentially improving survival rates.
How similar studies have performed: While this approach is novel in its specific combination, similar studies using targeted therapies with radiation and chemotherapy have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Steven H Lin — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.