Anti-Cancer Viral Therapy + Chemoradiation for Esophageal Cancer

Recruiting at 16 trial locations

Overseen by Geoffrey 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.

Research Team

Geoffrey Y Ku

Principal Investigator

NRG Oncology

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 have another cancer that does not affect this treatment's safety or effectiveness.

I am not pregnant and agree to use birth control.

I have completed all required tests for my lung cancer diagnosis.

Exclusion Criteria

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

I have a history of heart disease.

My cancer has spread to nearby structures.

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Paclitaxel (Anti-metabolites)
• Radiation Therapy (Radiation)
• Telomelysin™ (Virus Therapy)

Trial Overview 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.

Participant Groups

Group I: Treatment (OBP-301, carboplatin, paclitaxel, radiation) Experimental Treatment 4 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 Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+