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

NCT02718443 | Completed Phase 1 DMC

• 1 other identifier: VXM01-02-DE
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (7)

• Immune Response by Enzyme Linked Immuno Spot (ELISpot)

  12 months

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

  12 months

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

  12 months

• Tumor immune cell infiltration by tumor tissue immunohistochemistry

  35 days

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

  12 months

Study Arms (1)

VXM01

EXPERIMENTAL

VXM01 10E6 or 10E7 CFU

Drug: VXM01

Interventions

VXM01 DRUG

Oral immunotherapy targeting VEGFR2

VXM01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vaximm GmbH: lead

Study Sites (1)

Neurology Clinic and National Center for Tumor Diseases

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Wolfgang Wick, MD

  Neurology Clinic and National Center for Tumor Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 24, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: July 1, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)