VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vaximm GmbH
ClinicalTrials.gov Identifier:
NCT01486329
First received: December 2, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

First-in-human phase I dose escalation study in patients with locally advanced, inoperable and stage IV pancreatic cancer to examine safety, tolerability, and immune response to the investigational VEGFR-2 DNA vaccine VXM01 to examine safety and tolerability, clinical and immunogenic response to the investigational vascular endothelial growth factor receptor 2 (VEGFR-2) DNA vaccine VXM01, and to define the maximum tolerated dose.


Condition Intervention Phase
Stage IV Pancreatic Cancer
Biological: VXM01
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer to Examine Safety, Tolerability, and Immune Response to the Investigational VEGFR-2 DNA Vaccine VXM01

Resource links provided by NLM:


Further study details as provided by Vaximm GmbH:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 38 days ] [ Designated as safety issue: Yes ]
    Number of dose-limiting toxicities and maximum tolerated dose


Secondary Outcome Measures:
  • Immune response [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Number of immune positive patients

  • Tumor staging [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Tumor staging according to RECIST criteria

  • Tumor perfusion [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Tumor perfusion determined by DCE-MRI


Estimated Enrollment: 72
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VXM01
Investigational anti-angiogenic live cancer vaccine
Biological: VXM01
Live anti-angiogenic cancer vaccine drink solution, escalating dose
Placebo Comparator: Placebo
Placebo control
Biological: Placebo
Drink solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent, signed and dated
  • Locally advanced, inoperable and stage IV pancreatic cancer patients according to UICC based on diagnostic imaging using computer-tomography (CT) or histological examinations
  • Male or post-menopausal female
  • Age above or equal to 18 years
  • Chemotherapy naïve within 60 days before screening visit except gemcitabine treatment
  • Karnovsky index >70
  • Life expectancy >3 months
  • Adequate renal, hepatic, and bone marrow function
  • Absolute neutrophil count >1500/µL
  • Hemoglobin >10 g/dL
  • Platelets >75000/µL
  • Prothrombin time and international normalized ratio (INR) <1.5 times upper limit of normal (ULN) (except under anticoagulant treatment)
  • Aspartate aminotransferase <4 times ULN
  • Alanine aminotransferase <4 times ULN
  • Total bilirubin <3 times ULN
  • Creatinine clearance estimated according to Cockcroft-Gault >30 mL/min
  • Proteinuria <1 g protein on 24 h urine collection

Exclusion Criteria:

  • State after pancreas resection (complete or partial)
  • Resectable disease
  • Drug trial participation within 60 days before screening visit
  • Other previous or current malignancy except basal or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for <2 years
  • Prior vaccination with Ty21a
  • 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
  • Hemoptysis within 6 months before randomization
  • Esophageal varices
  • Upper or lower gastrointestinal bleeding within 6 months before randomization
  • Significant traumatic injury within 4 weeks before randomization
  • Non-healing wound, 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
  • Bowel obstruction within the last 30 days before screening visit
  • Liver cirrhosis ≥ grade B according to Child-Pugh Score-Classification
  • Presence of any acute or chronic systemic infection
  • Radiotherapy within 4 weeks before randomization
  • Major surgical procedures, or open biopsy within 4 weeks before randomization
  • Fine needle aspiration within 7 days before randomization
  • Chronic concurrent therapy within 2 weeks before and during the double-blind study period with:

    • Corticosteroids (except steroids for adrenal failure) or immunosuppressive agents
    • Antibiotics
    • Bevacizumab
    • Any epidermal growth factor receptor inhibitor
    • Chemotherapy except gemcitabine before Day 10
  • Multi-drug resistant gram-negative germ
  • Pregnancy
  • Lactation
  • Inability to comply with study and/or follow-up procedures
  • 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 history of drug hypersensitivity
  • Any condition which results in an undue risk for the patient during the study participation according to the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486329

Locations
Germany
Clinic of General Surgery
Heidelberg, Germany, 69120
Sponsors and Collaborators
Vaximm GmbH
Investigators
Principal Investigator: Thomas Schmidt, MD University Clinics, Heidelberg
  More Information

No publications provided by Vaximm GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vaximm GmbH
ClinicalTrials.gov Identifier: NCT01486329     History of Changes
Other Study ID Numbers: VXM01-01-DE
Study First Received: December 2, 2011
Last Updated: July 7, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Vaximm GmbH:
Pancreatic cancer
Cancer vaccine
Gemcitabine
Inoperable
Gemcitabine chemotherapy
Locally advanced

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014