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Patients in Cohort 1 will receive ADU-623 at a dose of 3 x 10\^7cfu by intravenous infusion (IV) over 2 hours on Day 0, Day 21, Day 42, and Day 63. Each dose is followed by a 3-day course or antibiotics. Patients will receive a 7-day course of antibiotics starting at the end of treatment visit.

Patients in Cohort 2 will receive ADU-623 at a dose of 3 x 10\^8cfu by intravenous infusion (IV) over 2 hours on Day 0, Day 21, Day 42, and Day 63. Each dose is followed by a 3-day course or antibiotics. Patients will receive a 7-day course of antibiotics starting at the end of treatment visit.

Patients in Cohort 3 will receive ADU-623 at a dose of 3 x 10\^9cfu by intravenous infusion (IV) over 2 hours on Day 0, Day 21, Day 42, and Day 63. Each dose is followed by a 3-day course or antibiotics. Patients will receive a 7-day course of antibiotics starting at the end of treatment visit.

Four doses of IV ADU-623 at a dose of 3 x 10\^7cfu

Cohort 1

Four doses of IV ADU-623 at a dose of 3 x 10\^8cfu

Cohort 2

Four doses of IV ADU-623 at a dose of 3 x 10\^9cfu

Cohort 3

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.

Antibiotics

Marka Crittenden, MD, PhD

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.

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

Data generated by this study will be shared with the collaborator, Aduro BioTech.

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.

The efficacy of therapy on tumor burden and time to progression will be assessed by MRI.

Innate and adaptive immunologic response will be assessed by looking at changes in cytokines and changes in cellular and humoral immunity.

Aduro Biotech, Inc.

Providence Health & Services

XL184

This is a study of multiple regimens of single-agent XL184 in subjects with grade IV astrocytic tumor in first or second relapse. The Randomized Phase of the study will evaluate the safety, tolerability, and preliminary efficacy of four XL184 dosing regimens in separate study arms. Subjects will be randomized to one of the study arms, which will not be blinded. After the Randomized Phase, additional subjects will be enrolled to further expand one study arm in the Expansion Phase.

Study of Multiple Doses and Regimens of XL184 (Cabozantinib) in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse

A Phase 2 Non-Comparative Randomized Open-Label Study of Multiple Regimens of Single-Agent XL184 in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse

Exelixis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I Study of Safety and Immunogenicity of ADU-623	NCT01967758	Astrocytic Tumo... Glioblastoma Mu... Anaplastic Astr... Brain Tumor	Cohort 1 Cohort 2 Cohort 3 Antibiotics	18 Years -	Providence Health & Services
Study of Multiple Doses and Regimens of XL184 (Cabozantinib) in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse	NCT01068782	Astrocytic Tumo...	XL184	18 Years -	Exelixis

Spots Global Cancer Trial Database for astrocytic tumors