cancer, advanced solid tumors kanker, gemetastaseerde solide tumor
Conditions
Interventions
Patients participating in the study will receive a total of 3 IM injections with hVEGF26-104/RFASE.
Sponsors
VU University Medical Center
Eligibility
Inclusion 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 50ml/min; 9. 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, has a negative pregnancy test and has agreed to continue adequate contraception for as long as VEGF is neutralized; 10. PT-INR/PTT < 1.5 x ULN, unless coumarin derivatives are used 11. 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
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. Primary or secondary immunodeficiency; 9. Treatment with a glucocorticoid derivative in an equivalent dose of ¡Ý 10mg prednisone a day; 10. Female patients: the patient is pregnant or lactating; 11. Uncontrolled auto-immune diseases 12. Primary or secondary immunodeficiency, including HIV 13. When the patient is scheduled to receive any other anticancer treatments. 14. Chemotherapy within 28 days prior to the initiation of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To investigate the safety and tolerability profile of the therapeutic vaccine hVEGF26-104/RFASE; 2. To determine the effective dose of hVEGF26-104/RFASE required to neutralize VEGF in serum, defined as a VEGF level below 9,0 pg/mL. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The anti-VEGF antibody titer, induced by hVEGF26-104/RFASE administration; 2. To determine the effective dose of hVEGF26-104/RFASE required to neutralize VEGF in plasma and in a platelet sample; 3. The effect of VEGF neutralization in a functional Ba/F3-R2 cell proliferation assay. | — |
Contacts
Public ContactH.M.W. Verheul
De Boelelaan 1117
Outcome results
None listed