Trials / Active Not Recruiting

Active Not RecruitingNCT04391049

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

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

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 16 (actual)

Sponsor: NRG Oncology · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine if the addition of OBP-301 to chemoradiation with carboplatin/paclitaxel is safe. SECONDARY OBJECTIVES: I. To assess toxicities associated with the addition of OBP-301 to chemoradiation. II. To assess the number of clinical complete responses (cCR). III. To assess the number of patients alive/without progression (progression-free survival \[PFS\]) and the number of patients alive (overall survival \[OS\]) at 1 and 2 years. EXPLORATORY OBJECTIVE: I. To report correlate outcomes - cCR, PFS and OS - with immune and virus-based correlative assays. OUTLINE: This study will evaluate an initial dose of OBP-301 and a de-escalated dose, if needed. Patients receive OBP-301 by intratumoral injection via endoscopy on days -3, 12, and 26. Patients also receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, and 29, and undergo radiation therapy on Monday through Friday beginning day 1 for 28 fractions over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 and 6-8 weeks, then every 3 months for 2 years.

Conditions

Interventions

Type	Name	Description
DRUG	Carboplatin	Intravenously (IV)
DRUG	Paclitaxel	Intravenously (IV)
RADIATION	Radiation Therapy	Daily fractions
BIOLOGICAL	Telomerase-specific Type 5 Adenovirus OBP-301	Intra-tumoral injection

Timeline

Start date: 2021-12-02
Primary completion: 2024-10-06
Completion: 2026-10-01
First posted: 2020-05-18
Last updated: 2026-01-30
Results posted: 2025-05-29

Locations

17 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04391049. Inclusion in this directory is not an endorsement.