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

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.

Conditions

• Advanced Esophageal Adenocarcinoma
• Advanced Gastroesophageal Junction Adenocarcinoma
• Clinical Stage II Esophageal Adenocarcinoma AJCC v8
• Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Adenocarcinoma AJCC v8
• Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage II Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Unresectable Gastroesophageal Junction Adenocarcinoma
• Squamous Cell Carcinoma
• Squamous 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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  lead OTHER

Principal Investigators

• Geoffrey Y Ku · NRG Oncology

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-02

Primary Completion

2024-10-06

Completion

2026-10-01

FDA Drug

Yes

Countries

• United States

Study Locations