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ACTIVE NOT RECRUITING
NCT04391049
PHASE1

Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tumor cells (although there is a small risk that it can also infect normal cells). Chemotherapy drugs, such as carboplatin and paclitaxel, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving OBP-301 with chemotherapy and radiation therapy may work better than standard chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal cancer.

Official title: Phase I Trial With Expansion Cohort of OBP-301 (Telomelysin™) and Definitive Chemoradiation for Patients With Locally Advanced Esophageal and Gastroesophageal Cancer Who Are Not Candidates for Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2021-12-02

Completion Date

2026-10-01

Last Updated

2026-01-30

Healthy Volunteers

No

Conditions

Advanced Esophageal AdenocarcinomaAdvanced Gastroesophageal Junction AdenocarcinomaClinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage III Esophageal Adenocarcinoma AJCC v8Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Unresectable Gastroesophageal Junction AdenocarcinomaSquamous Cell CarcinomaSquamous Cell Cancer

Interventions

DRUG

Carboplatin

Intravenously (IV)

DRUG

Paclitaxel

Intravenously (IV)

RADIATION

Radiation Therapy

Daily fractions

BIOLOGICAL

Telomerase-specific Type 5 Adenovirus OBP-301

Intra-tumoral injection

Locations (17)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

City of Hope Upland

Upland, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Kansas Clinical Research Center

Fairway, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

M D Anderson Cancer Center

Houston, Texas, United States