Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Brain Neoplasms

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Anaplastic Astrocytoma

Neuroepithelioma

Anti-Infective Agents

All Drugs and Chemicals

Anti-Dyskinesia Agents

Micronutrients

Hematinics

Vitamins

Amoxicillin

Vaccines

Amoxicillin-Potassium Clavulanate Combination

Anti-Bacterial Agents

Immunomodulating Agents

Penicillins

Antibiotics, Antitubercular

Trimethoprim, Sulfamethoxazole Drug Combination

Trimethoprim

Sulfamethoxazole

Clavulanic Acid

Clavulanic Acids

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

beta-Lactamase Inhibitors

Folinic Acid

Folate

Vitamin B9

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

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Gemcitabine

Oxaliplatin

Lapatinib

Weekly gem + GW572016, 1000mg/day (combination)

Weekly gem + GW572016, 1500 mg/day (combination)

GEMOX + GW572016 1000 mg/day (combination)

GEMOX + GW572016 1500 mg/day (combination)

cohort 1

cohort 2

cohort 3

cohort 4

howard Safran, MD

A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema

The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each dose level to assess toxicity. To better assess the safety at the final dose level in both Stage I and Stage II, the number of patients in the cohort at the Maximum Tolerated Dose for both Stages will be expanded to 10. Therefore approximately 34-37 patients will be treated on this study.

Trial finished and no further data will be collected.

A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema

BrUOG-PA-205 A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema GSK Study ProtocolGSK #103556

To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs

To assess clinical activity of GW572016 with gemcitabine and with the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers.

GlaxoSmithKline

Brown University

Principal Investigator

Cohort 1: Weekly gem + GW572016, 1000mg/day.

Cohort 2: Weekly gem + GW572016, 1500 mg/day.

Cohort 4

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

participant number correlates to all enrolled patients treated on this study as a whole which is the way in which the abstract was written and therefore how these results are entered

Howard Safran, MD

Cohorts 1

Toxicity (Number of Patients Who Experiened DLTs)

Number of Patients Who Experienced a Partial Response

Cohort 1: Weekly gem + GW572016, 1000mg/day. (combination)

Cohort 2: Weekly gem + GW572016, 1500 mg/day. (combination)

Cohort 3: GEMOX + GW572016 1000 mg/day. (combination)

Cohort 4: GEMOX + GW572016 1500 mg/day.(combination)

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
A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema	NCT00439179	Metastatic Panc...	cohort 1 cohort 2 cohort 3 cohort 4	18 Years -	Brown University

Spots Global Cancer Trial Database for cohort 1

Every month we try and update this database with for cohort 1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cohort 1

Every month we try and update this database with for cohort 1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cohort 1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.