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Astrocytic TumorsPhase 1NCT01967758

Phase I Study of Safety and Immunogenicity of ADU-623

A Phase 1 study testing Cohort 1, Cohort 2 and Cohort 3 in people with Astrocytic Tumors and Glioblastoma Multiforme, run by Providence Health & Services at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cohort 1, Cohort 2 and Cohort 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
8 Jan 2014to 15 Aug 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a pathologic diagnosis of WHO Grade III or Grade IV astrocytic tumors that have completed standard of care or with radiographic evidence of progression following standard of care.
  • Tumor tissue blocks available to perform both EGFRvIII and NY-ESO-1 testing
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) 70-100
  • Age 18 years or above
  • Have a life expectancy of more than 12 weeks
  • Laboratory values (performed within 5 days) within designated range.
  • For women and men of childbearing potential, an acceptable method of highly effective contraception
  • Ability to give informed consent and comply with the protocol.

Who cannot join

  • Have a known allergy to both penicillin and sulfa
  • Have artificial (prosthetic) joint(s), orthopedic screw(s), metal plate(s) or other exogenous implant(s) or device(s) that cannot be easily removed (i.e., prosthetic heart valves).
  • Have any evidence of hepatic cirrhosis or clinical or radiographic ascites.
  • Have radiographic or clinically significant pleural effusion.
  • Receipt of prophylactic vaccine within 28 days of study treatment.
  • Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual).
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  • History of allergy to yeast or any other component of the ADU-623 vaccine (e.g., glycerol).
  • Have an immunodeficiency disease or immunocompromised state (e.g., use of immunosuppressive agents; chemotherapy or radiation therapy within 14 days of study treatment).
  • Have had major surgery or significant traumatic injury occurring within 28 days before treatment administration or anticipated surgery or procedure requiring general anesthesia during study participation (including 28 days after last dose of ADU-623).
  • Use of more than 4 grams per day of acetaminophen.
  • Have received an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administration.
  • Have an unhealed surgical wound.
  • Have clinically significant heart disease (such as uncontrolled angina, myocardial infarction with the last 3 months, congestive heart failure of New York Heart Association III or IV).
  • Have valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis.
  • Have an intercurrent illness that is either life-threatening or of clinical significance such that it might limit compliance with study requirements including, but not limited to, ongoing or active infection, metabolic or neurological disease, peripheral vascular disease or psychiatric illness.
  • Have insufficient peripheral venous access to permit completion of the study dosing and compliance with study phlebotomy regimen.
  • Have received a diagnosis of HIV, HCV, or HBV (patients with hepatitis C antibody positive may be enrolled if they are confirmed with negative viral load at screening).
  • Have an active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment.
  • Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
  • Pregnant or lactating women, as treatment has unknown effect on the embryo or child.
  • Patients requiring chronic corticosteroid use will be excluded as this may mask toxic effects related to the vaccine and may prevent the development of effective immune responses following vaccination.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Providence Cancer Center

    Portland, Oregon, 97213

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
Cohort 1, Cohort 2, Cohort 3, Antibiotics
Keywords
Astrocytic Tumors, Glioblastoma Multiforme, Anaplastic Astrocytoma, Brain Tumor, Brain Cancer, Immunotherapy
Medical subject headings
Glioblastoma, Astrocytoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cohort 1Biological

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

  • Cohort 2Biological

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

  • Cohort 3Biological

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

  • AntibioticsDrug

    Also called Amoxicillin, Augmentin, trimethoprim / sulfamethoxazole, Bactrim

    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.

Study groups in NCT01967758
Study groupRoleWhat they receive
Cohort 1ExperimentalPatients 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.
Receives: Biological: Cohort 1; Drug: Antibiotics
Cohort 2ExperimentalPatients 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.
Receives: Biological: Cohort 2; Drug: Antibiotics
Cohort 3ExperimentalPatients 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.
Receives: Biological: Cohort 3; Drug: Antibiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 91 Days

Secondary outcomes (2)

  1. 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.

    Measured: 24 months

  2. Immune Response

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

    Measured: 91 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2013 (estimated)
  2. Study start8 Jan 2014
  3. Primary completion18 Jun 2018
  4. Study completion15 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01967758
Sponsor's protocol ID
13-012A
Status last verified
Aug 2018
First submitted
18 Oct 2013
Last updated
17 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Data generated by this study will be shared with the collaborator, Aduro BioTech.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cohort 1, Cohort 2 and Cohort 3 in people with Astrocytic Tumors and Glioblastoma Multiforme, run by Providence Health & Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (time frame: 91 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01967758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.

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