Sodium selenite in patients with advanced carcinoma: A phase I/II study with 99 hours of continuous selenite treatment followed by chemotherapy

Conditions

Advanced carcinoma

Brief summary

The optimal dose, i.e., the dose with the best clinical response without DLT. Clinical response will be evaluated using RECIST 1.1 on CT scans taken before and after the selenite treatment. Toxicity will be measured according to the CTCAE V4.0 system (as in previous SECAR studies, to allow for direct comparisons).

Detailed description

Tumor response to chemotherapy following selenite treatment as evaluated using RECIST 1.1 on CT scans taken before and after chemotherapy., Improvement of disease symptoms as measured by improvement in WHO performance status assessed before, during and after treatments, Improvement of disease symptoms according to tumour markers or improvement of other abnormal laboratory results measured before, during and after treatments., Description of the pharmacokinetics of selenium and selenite. Plasma, erythrocytes and urine for these analyses will be collected before, during and after the selenite infusion., Correlation between plasma levels and erythrocyte levels of selenite and clinical responses and AE’s., The effect of high dose selenite-infusion on immunological variables, Overall survival as measured from the first selenite treatment day until death of any cause.

Related papers

No related papers found yet.

Interventions

DRUGselesyn 500 micrograms/10 ml

DRUGsolution for injection (50 micrograms/ml)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The optimal dose, i.e., the dose with the best clinical response without DLT. Clinical response will be evaluated using RECIST 1.1 on CT scans taken before and after the selenite treatment. Toxicity will be measured according to the CTCAE V4.0 system (as in previous SECAR studies, to allow for direct comparisons).	—

Secondary

Measure	Time frame
Tumor response to chemotherapy following selenite treatment as evaluated using RECIST 1.1 on CT scans taken before and after chemotherapy., Improvement of disease symptoms as measured by improvement in WHO performance status assessed before, during and after treatments, Improvement of disease symptoms according to tumour markers or improvement of other abnormal laboratory results measured before, during and after treatments., Description of the pharmacokinetics of selenium and selenite. Plasma, erythrocytes and urine for these analyses will be collected before, during and after the selenite infusion., Correlation between plasma levels and erythrocyte levels of selenite and clinical responses and AE’s., The effect of high dose selenite-infusion on immunological variables, Overall survival as measured from the first selenite treatment day until death of any cause.	—

Measure

Time frame

Tumor response to chemotherapy following selenite treatment as evaluated using RECIST 1.1 on CT scans taken before and after chemotherapy., Improvement of disease symptoms as measured by improvement in WHO performance status assessed before, during and after treatments, Improvement of disease symptoms according to tumour markers or improvement of other abnormal laboratory results measured before, during and after treatments., Description of the pharmacokinetics of selenium and selenite. Plasma, erythrocytes and urine for these analyses will be collected before, during and after the selenite infusion., Correlation between plasma levels and erythrocyte levels of selenite and clinical responses and AE’s., The effect of high dose selenite-infusion on immunological variables, Overall survival as measured from the first selenite treatment day until death of any cause.

—

Countries

Sweden

Outcome results

None listed