Table 1. Full inclusion and exclusion criteria.
Inclusion criteria | Exclusion criteria |
---|---|
Age 18 years or older. | History of idiopathic seizure disorder, psychosis or schizophrenia. |
A previous histopathologically verified diagnosis of glioblastoma/
gliosarcoma (later referred to as only glioblastoma) now presenting with a first-time progression/recurrence documented by MRI. |
Uncontrolled hypertension (i.e. systolic BP > 180 mmHg) and a
diagnosis of congestive heart failure |
Planned treatment of recurrence with chemotherapeutic alkylating
agents |
Received radiotherapy within the 3 months before the diagnosis
of tumor progression to reduce risk of misdiagnosis due to pseudoprogression. |
Karnofsky performance status of 60 – 100 22. | Addiction to alcohol or drugs. |
At inclusion not receiving another experimental treatment, including
compassionate use programs, for glioblastoma |
Pregnant and/or breastfeeding and women of childbearing
potential who do not have a negative pregnancy test taken no longer than 14 days prior to randomization. |
Able to take oral medications. | History of liver disease. |
No known allergy to DSF or copper. | History of Wilson's disease. |
Absolute neutrophil count ≥ 1,500/mcL and platelets ≥ 100,000/mcL | History of hemochromatosis. |
Willingness to refrain from ingestion of alcoholic beverages while in
the study is a criterion to be randomized. However, once randomized alcohol abstinence only affects the group treated with DSF |
Nickel hypersensitivity 8 |
Need for metronidazole, warfarin and/or theophylline medication
since their metabolism may be influenced by DSF. |
|
Patients who are taking medications metabolized by cytochrome
P450 2E1 |
|
Unfit for participation for any other reason judged by the
including physician |