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Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma (SECAR)

Published: November 25, 2013

Primary Outcome Measures:

  • Maximal tolerable dose (phase I, ongoing) [ Time Frame: within three year ] [ Designated as safety issue: Yes ]
    To find which kind and grade of toxicities that are dose-limiting

Secondary Outcome Measures:

  • Responses [ Time Frame: Two years within the phase I study ] [ Designated as safety issue: Yes ]
    Responses are measured essentially by CT scan or PET-CT-scan. During the Phase II study, responses are the primary criteria but in the phase I study toxicity is the main criteria.

Detailed Description:

  • Patients: With advanced malignant disease, any kind, in which all standard treatment has been tried, but still progression. In sufficient good performance status (ps 0-2)to get more treatment: first selenite and immediately afterwards chemotherapy (since an additive or synergistic effect from selenite and chemotherapy has been found).
  • Treatment: We have performed the initial study with sodium selenite i.v. daily, 10 treatments during 2 weeks. The week after that response evaluation and then chemotherapy. In each patient, his or her first line chemotherapy treatment is given, since in vitro studies indicate that selenite might reverse resistance. In the modified protocol, a 2 days continuous infusion will be performed.
  • Toxicity evaluation (main criteria in phase I): Meeting a doctor once a week during selenite treatment and before each chemotherapy treatment and at End of treatment. Meeting a nurse each treatment day during selenite treatment. Blood samples for liver, kidney, blood and thyroid values. Plasma samples for selenite concentration during treatment.
  • Response evaluation (to be: main criteria in phase II and studied also in phase I): CT scan just before and after selenite treatment and after chemotherapy. From May 2011 FDG-PET-CT-scan just before and after selenite treatment. Cytokeratin and cytokeratin fragments evaluation.

Eligibility 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
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