NL-OMON47883
Completed
Not Applicable
A phase I open-label clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced solid tumors - Phase I study on VEGF vaccination in metastatic solid tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- advanced cancer
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 27
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically confirmed advanced, solid malignancy.
- •2\. Refractory or not amenable to standard therapy
- •3\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\.
- •4\. Willing and able to give written informed consent
- •5\. Patient is \* 18 years of age at the time of signature of the informed consent
- •6\. Adequate hematological function: Absolute neutrophil count (ANC) \* 1\.5 x 109/L, platelets \* 100 x 109/L, Hemoglobin \* 6\.0 mmol/L.
- •7\. 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).
- •8\. Adequate renal function: eGFR \* 50ml/min
- •9\. PT\-INR/PTT \< 1\.5 x ULN, unless coumarin derivatives are used
- •10\. 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)
Exclusion Criteria
- •1\. Major surgery within 28 days before the initiation of study treatment
- •2\. Any serious non\-healing wounds, ulcers, or bone fractures within 28 days prior to the initiation of study treatment.
- •3\. Deep venous thrombosis (DVT) or pulmonary embolus (PE) within 1 year prior to the initiation of study treatment.
- •4\. Uncontrolled hypertension (systolic \> 150 mmHg and/or diastolic \> 100 mmHg)
- •5\. The patient is scheduled to receive another vaccination during the DLT period.
- •6\. A previous serious allergic reaction to a vaccine such as angioedema and anaphylaxis.
- •7\. Treatment with bevacizumab within 6 weeks prior to the initiation of study treatment.
- •8\. Uncontrolled auto\-immune diseases
- •9\. Primary or secondary immunodeficiency, including HIV
- •10\. Treatment with a glucocorticoid derivative in an equivalent dose of \* 10mg prednisone a day.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A phase I-IIa clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced cancerAdvanced solid tumorsMedDRA version: 16.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-002663-25-NLVU University Medical Center27
Active, not recruiting
Phase 1
To evaluate the safety and tolerability of Cytokine cocktail therapy in healthy volunteers from healthy donorsCTRI/2020/05/025432Health Care Global HCG Cancer CentreInternational stemcell services ltd
Completed
Not Applicable
A phase I-II open label clinical trial, evaluating the efficacy and safety of administration of the therapeutic vaccine PEP-223/CoVaccine HT, to hormone treatment naive, immunocompetent subjects with T1-3, N0-1/x, M0 prostate cancer, eligible for hormone therapy.NL-OMON35662Pepscan Therapeutics B.V.12
Active, not recruiting
Phase 1
Clinical study in patients with bladder cancerEUCTR2014-005330-58-NLSAKK (Schweizerische Arbeitsgemeinschaft für klinische Krebsforschung)39
Completed
Phase 1
Phase I clinical trial to evaluate the safety,tolerance and immune response ofChikungunya vaccine in healthy adults of 18 to 50 years ageCTRI/2020/04/024533Bharat Biotech International limited20