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GlioblastomaPhase 1NCT02718443

VXM01 Phase I Pilot Study in Patients With Operable Recurrence of a Glioblastoma

A Phase 1 study testing VXM01 in people with Glioblastoma, run by Vaximm GmbH at 1 site in Germany.

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

VXM01 phase I pilot study in patients with operable recurrence of a glioblastoma to examine safety, tolerability, immune and biomarker response to the investigational VEGFR-2 DNA vaccine VXM01 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
VXM01
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteGermany
Study dates
May 2016to Jul 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

  • Written informed consent, signed and dated
  • Histologically diagnosed intracranial supratentorial malignant glioma (contrast-enhancing anaplastic astrocytoma WHO Grade III or glioblastoma WHO Grade IV).
  • Male or female patients who must be post-menopausal for at least 2 years or surgically sterile.
  • Age ≥18 years
  • Evidence of tumor progression following at least one therapy regimen that must have contained radiation and chemotherapy with temozolamid, as measured by MRI
  • Candidates for a tumor reoperation
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  • Neurosurgical intervention should be postponable for 30 days
  • Laboratory results (clinical chemistry, hematology, urine, liver enzymes, creatinine) without clinically relevant abnormalities
  • Patients must be able to undergo MRI
  • No concomitant medication with dexamethasone at the time of vaccination
  • No active infection at the time of vaccination
  • Karnofsky performance status >70
  • Appropriate hematologic parameters (for immunomonitoring): leukocytes ≥4.0 x 109 / L, lymphocytes ≥0.6 x 109 / L
  • Tumor samples available for pathology review, central detection of T-cell responses in the peripheral blood and in the tumor tissue
  • No medical or social conditions that may interfere with study outcome and follow-up

Who cannot join

  • Treatment in any other clinical trial within 30 days before screening
  • Known positive test results for Hepatitis B surface antigen , hepatitis C virus antibodies, human immunodeficiency virus antibodies -1/-2
  • Any other condition or treatment that, in the opinion of the investigator, might interfere with the study or current drug or substance abuse
  • Inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
  • Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
  • Pregnancy or breast feeding
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  • Positive for anti-typhoid IgG/IgM antibodies according to the onsite test on Day 0
  • Cardiovascular disease defined as:
  • Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
  • Arterial thromboembolic event within 6 months before randomization including:
  • Myocardial infarction
  • Unstable angina pectoris
  • Cerebrovascular accident
  • Transient ischemic attack
  • Congestive heart failure New York Heart Association grade III to IV
  • Serious ventricular arrhythmia requiring medication
  • Clinically significant peripheral artery disease > grade 2b according to Fontaine
  • Intracranial ischemic stroke within 6 months before randomization
  • History of intracranial hemorrhage
  • Hemoptysis within 6 months before randomization
  • Esophageal varices
  • Upper or lower gastrointestinal bleeding within 6 months before inclusion (Day 0)
  • Significant traumatic injury or surgery within 4 weeks before randomization
  • Non-healing wound, incomplete wound healing, bone fracture or any history of gastrointestinal ulcers within three years before inclusion, or positive gastroscopy within 3 months before inclusion
  • Gastrointestinal fistula
  • Thrombolysis therapy within 4 weeks before randomization
  • Presence of any acute or chronic systemic infection
  • Major surgical procedures, or open biopsy within 4 weeks before randomization
  • Chronic concurrent therapy within 2 weeks before and during the treatment period up to Day 35 with:
  • Corticosteroids (except steroids for adrenal failure or emesis prophylaxis up to 4 mg daily dose) or immunosuppressive agents
  • Antibiotics
  • Bevacizumab
  • Any cancer anti-angiogenic treatment
  • Chemotherapy from screening until reoperation (Day 35)
  • Known multi-drug resistant gram-negative germ
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the study results or render the patient at high risk for treatment complications
  • Women of childbearing potential
  • Any condition which results in an undue risk for the patient during the study participation according to the investigator

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Neurology Clinic and National Center for Tumor Diseases

    Heidelberg, 69120

Other trials in Germany

About this study

Official title: VXM01 Phase I Pilot Study in Patients With Operable Recurrence of a Glioblastoma to Examine Safety, Tolerability, Immune and Biomarker Response to the Investigational VEGFR-2 DNA Vaccine VXM01

VXM01 phase I pilot study in patients with operable recurrence of a glioblastoma to examine safety, tolerability, immune and biomarker response to the investigational VEGFR-2 DNA vaccine VXM01

Conditions
Glioblastoma
Being tested
VXM01
Medical subject headings
Glioblastoma

What participants receive

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

  • VXM01Drug

    Oral immunotherapy targeting VEGFR2

Study groups in NCT02718443
Study groupRoleWhat they receive
VXM01ExperimentalVXM01 10E6 or 10E7 CFU
Receives: Drug: VXM01

What is being measured

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

  1. Safety and tolerability taking into account treatment-limiting toxicities (TLTs)

    AEs listed together with information on onset, duration, severity, seriousness, relationship to the study drug, relationship to chemotherapy and to the underlying disease, outcome, and action taken. Frequency tables by System Organ Class and preferred term.

    Measured: 12 months

Secondary outcomes (7)

  1. Immune Response by Enzyme Linked Immuno Spot (ELISpot)

    Patient-individual VEGFR-2 specific T cell responses will be determined by ELISpot using cryopreserved peripheral blood mononuclear cells

    Measured: 12 months

  2. Serum biomarker Response by Enzyme Linked Immuno Sorbent Assay (ELISA)

    Biomarkers including VEGF A and Collagen IV determined from periphaeral blood samples

    Measured: 12 months

  3. Vascular normalization index (VNI) including tumor perfusion acc. to Sorensen 2009

    Determined by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) (ktrans), dynamic susceptibility contrast imaging (DSC), blood volume maps (cerebral blood volume [CBV] of smaller vessels) and collagen IV

    Measured: 12 months

  4. Tumor immune cell infiltration by tumor tissue immunohistochemistry

    Tumor tissue immunohistochemistry staining including Evaluations of effector T cell infiltration, regulatory T-cells (Treg), myeloid derived suppressor cells (MDSC)

    Measured: 35 days

  5. Tumor response or progression on MRI acc. to Response Assessment in Neuro-Oncology (RANO) criteria

    MRI comprising the National Brain Tumor Society /EORTC protocol for gliomas

    Measured: 12 months

  6. Clinical Response including time to progression, progression free survival, overall survival

    Measured: 12 months

  7. Biodistribution and shedding of VXM01 bacteria

    Bacterial vector tissue biodistribution, persistence, and shedding of viable Ty21a bacteria (VXM01) determined by cultivation of stool samples

    Measured: 10 days

Timeline

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

  1. First posted24 Mar 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionAug 2017
  4. Study completionJul 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02718443
Sponsor's protocol ID
VXM01-02-DE
Status last verified
Oct 2018
First submitted
16 Mar 2016
Last updated
19 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VXM01 in people with Glioblastoma, run by Vaximm GmbH at 1 site in Germany.

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 15 inclusion and 38 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 19 Oct 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 Germany. 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?

Safety and tolerability taking into account treatment-limiting toxicities (TLTs) (time frame: 12 months). 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 NCT02718443.

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 19 Oct 2018.

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