Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma
Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
In vitro studies have demonstrated that sodium selenite in sufficient concentration and
during sufficient time have a high tumoricidal capacity. This is found in many human cell
types as leukemia cells, mesothelioma and non-small cell lung cancer cells. A minority of
cell lines seem to be resistant. The question from a clinical point of view is: Is it
possible with respect to toxicity to administer sodium selenite to patients in sufficient
dose and during sufficient time to get responses in patients with cancer? We have performed
first part of phase-1 study and found MTD of 10.2 mg/m2 if given as 10 daily infusions during
12 days. We have recorded limited anti-tumor effect in this treatment regimen. However, in
vitro data suggest that low concentration of continuous exposure for 51 h is much more
effective. Now we are planning to continue the phase-I trial with modified protocol.
More specific:
1. Phase I: Find maximal tolerable dose with continuous infusion
2. Phase II: Use MTD and study responses, if any
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Karolinska University Hospital
Collaborators:
Cancer and Allergy Foundation Cancerfonden Cancerföreningen i Stockholm Region Stockholm Stockholm County Council, Sweden