Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Collaborators: Cancer and Allergy Foundation; Cancerfonden; Cancerföreningen i Stockholm; Region Stockholm; Stockholm County Council, Sweden
• Treatments: Selenious Acid; Sodium Selenite

Criteria

Inclusion Criteria:

• Advanced malignant tumor disease

• All standard treatments should have been tested, but the disease still progressing.

• In sufficient good performance status to get more treatment

• Informed consent

Exclusion Criteria:

• More than 1 active tumour disease

• Impaired capacity to cooperate

• Serious other disease such as heart or kidney disease that might give extra risk for complications and difficulties to interpret effect of the selenite treatment

• The tumour not possible to evaluate