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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Four doses of IV ADU-623 at a dose of 3 x 10\^7cfu
Four doses of IV ADU-623 at a dose of 3 x 10\^8cfu
Four doses of IV ADU-623 at a dose of 3 x 10\^9cfu
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.
Providence Cancer Center
Portland, Oregon, United States
Maximum Tolerated Dose
The primary objective of this trial is to determine the maximum tolerated dose (MTD)(up to a dose of 1x10\^9 cfu IV) and characterize the safety profile of ADU-623 vaccine in patients with recurrent WHO Grade III/IV Astrocytomas. The MTD will be defined as the highest dose at which none or one out of 6 patients experiences a dose-limiting toxicity (DLT) that is possibly or probably related to the vaccine.
Time frame: 91 Days
Tumor response based on magnetic resonance imaging (MRI) exam
The efficacy of therapy on tumor burden and time to progression will be assessed by MRI.
Time frame: 24 months
Immune Response
Innate and adaptive immunologic response will be assessed by looking at changes in cytokines and changes in cellular and humoral immunity.
Time frame: 91 Days
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