Status:
COMPLETED
Phase I Study on VEGF Vaccination in Metastatic Solid Tumors
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Immunovo B.V.
Conditions:
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objectives of this study are to investigate the safety and tolerability profile of the therapeutic vaccine hVEGF26-104/RFASE and to determine the effective dose of hVEGF26-104/RFASE requir...
Detailed Description
Angiogenesis (the formation of new blood vessels from pre-existing blood vessels) plays an important role in the growth and spread of tumors. Angiogenesis is regulated by a balance of activators and i...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced, solid malignancy.
- Refractory or not amenable to standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Please refer to Appendix II for more information.
- Willing and able to give written informed consent
- Patient is ≥ 18 years of age at the time of signature of the informed consent
- Adequate hematological function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, Hemoglobin ≥ 6.0 mmol/L.
- Adequate hepatic function: serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT and AST ≤ 2.5 x ULN (or ≤ 5 times ULN if liver metastases are present).
- Adequate renal function: eGFR ≥ 50ml/min
- PT-INR/PTT \< 1.5 x ULN, unless coumarin derivatives are used
- Activated partial thromboplastin time (APTT) \< 1.25 x ULN (therapeutic anticoagulation therapy is allowed, if this treatment can be interrupted for a biopsy as judged by the treating physician)
- Female patients of childbearing potential may be enrolled in the study, if the patient
- Has practiced adequate contraception for 30 days prior to first hVEGF26-104/RFASE administration.
- Negative pregnancy test
- Has agreed to continue adequate contraception for as long as VEGF is neutralized.
Exclusion
- Major surgery within 28 days before the initiation of study treatment
- Any serious non-healing wounds, ulcers, or bone fractures within 28 days prior to the initiation of study treatment.
- Deep venous thrombosis (DVT) or pulmonary embolus (PE) within 1 year prior to the initiation of study treatment.
- Uncontrolled hypertension (systolic \> 150 mmHg and/or diastolic \> 100 mmHg)
- The patient is scheduled to receive another vaccination during the DLT period.
- A previous serious allergic reaction to a vaccine such as angioedema and anaphylaxis.
- Treatment with bevacizumab within 6 weeks prior to the initiation of study treatment.
- Uncontrolled auto-immune diseases
- Primary or secondary immunodeficiency, including HIV
- Treatment with a glucocorticoid derivative in an equivalent dose of ≥ 10mg prednisone a day.
- Female patients: the patient is pregnant or lactating.
- When the patient is scheduled to receive any other anticancer treatments.
- Chemotherapy within 28 days prior to the initiation of study treatment.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02237638
Start Date
April 1 2014
End Date
January 1 2020
Last Update
April 19 2021
Active Locations (1)
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1
VU University Medical Center
Amsterdam, North Holland, Netherlands, 1081 HV