Anti-Cancer Viral Therapy + Chemoradiation for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen ByGeoffrey Y Ku

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a combination of a special virus, two chemotherapy drugs, and radiation therapy in patients with advanced esophageal or gastroesophageal cancer. The virus aims to kill cancer cells directly, while the chemotherapy and radiation help stop the cancer from growing and spreading.

Eligibility Criteria

This trial is for adults with advanced esophageal or gastroesophageal cancer who can't have surgery. They must be in good physical condition, not pregnant, and willing to use contraception. People with other cancers that won't affect this study can join too. But those with certain infections, previous treatments for their cancer, or serious health issues like uncontrolled diabetes cannot participate.

Inclusion Criteria

I am not pregnant and agree to use birth control.

My tumor at the stomach and esophagus junction is a specific type (Siewert I or II).

I am HIV positive, on treatment, and my viral load is undetectable.

I cannot have surgery but can undergo chemoradiation.

My tumor can be treated with direct injections and I can undergo 3 endoscopies.

Exclusion Criteria

I have a history of heart disease.

My cancer has spread to nearby structures.

I am currently breastfeeding.

My cancer has spread to other parts of my body.

I have had chemotherapy or radiotherapy for my cancer before.

I do not have uncontrolled diabetes or an active infection needing IV antibiotics.

I haven't taken immunosuppressive drugs in the last week.

Participant Groups

The trial tests Telomelysin™ (OBP-301), a virus targeting cancer cells, combined with chemotherapy drugs carboplatin and paclitaxel plus radiation therapy. The goal is to see if this mix works better than the usual chemo and radiation for these types of cancer.

1Treatment groups

Experimental Treatment

Group I: Treatment (OBP-301, carboplatin, paclitaxel, radiation)Experimental Treatment4 Interventions

Patients receive OBP-301(1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes on days 1, 8, 15, 22, and 29, and undergo radiation therapy on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: