metastasized neuroendocrine tumors (NETs)
Conditions
Interventions
14 days treatment with valproic acid (30mg/kg body weight/day) and hydralazine (150mg / day)
Sponsors
Erasmus MC, Rotterdam, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: • Age =18 years • Inoperable or metastasized neuroendocrine tumor with well-differentiated histology (grade 1 or 2) • SSTR2 negativity on 68Ga DOTATATE PET scan, defined as tumor uptake on 68Ga- DOTATATE PET CT below that of the liver
Exclusion criteria
Exclusion criteria: • Hypotension, defined as systolic blood pressure 3 times upper normal range • Uncontrolled hormonal symptoms including severe diarrhea, defined as >5 loose stools / day • Severe hypoalbuminemia, defined as serum albumin concentration <25g/L • Epilepsy • Known allergies / intolerances to valproic acid or hydralazine • Existing drug treatment which cannot be stopped and interacts or interferes with study drugs • Inability to provide informed consent • End of life care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the percentage of patients that will have an uptake of 68Ga-DOTATATE in the tumor equal to or above that of the liver after the 14 days treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety, as number of adverse events • Drug levels of valproic acid • Dosimetric evaluation of intra- and intertumoral SSTR2 expression • Leucocyte methylation analysis | — |
Contacts
Public ContactJulie Refardt
Erasmus MC
Outcome results
None listed