NCT01967758

Phase I Study of Safety and Immunogenicity of ADU-623

Phase I Study of Safety and Immunogenicity of ADU-623, a Live-attenuated Listeria Monocytogenes Strain (ΔactA/ΔinlB) Expressing the EGFRvIII-NY-ESO-1 Vaccine, in Patients With Treated and Recurrent WHO Grade III/IV Astrocytomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study for patients with brain tumors called astrocytic tumors. The study will enroll patients who have received standard treatment. The study will test a vaccine called ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see if ADU-623 can be given safely to brain cancer patients and what is the better dose to give patients among the three doses that planned to be tested. This study will also evaluate the length of time before patients' cancer worsens and if ADU-623 helps patients to live longer. The study will also measure the body's immune system response to ADU-623.

Detailed description

This Phase I clinical trial will examine the safety, tolerability and immunogenicity of a novel vaccine approach using a live-attenuated strain of Listeria monocytogenes expressing EGFRvIII and NY-ESO-1 antigens to induce proliferation of memory and effector T cells with the overall goal of promoting an immune response against high-grade astrocytic tumors.

Conditions

• Astrocytic Tumors
• Glioblastoma Multiforme
• Anaplastic Astrocytoma
• Brain Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Cohort 1	Four doses of IV ADU-623 at a dose of 3 x 10\^7cfu
BIOLOGICAL	Cohort 2	Four doses of IV ADU-623 at a dose of 3 x 10\^8cfu
BIOLOGICAL	Cohort 3	Four doses of IV ADU-623 at a dose of 3 x 10\^9cfu
DRUG	Antibiotics	A 3-day course of oral amoxicillin (500 mg three times per day) or trimethoprim/sulfamethoxazole in penicillin-allergic patients (160 mg trimethoprim / 800mg sulfamethoxazole at 12 hour intervals) will be initiated for each patient 3 days following each dose of ADU-623. Patients will receive a 7-day course of antibiotics starting at the end of treatment visit.

Timeline

• Start date: 2014-01-08
• Primary completion: 2018-06-18
• Completion: 2018-08-15
• First posted: 2013-10-23
• Last updated: 2018-08-17

Locations

1 site across 1 country: United States