Clinical trial · Interventional
Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma
Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma. A Phase I and Phase II Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
| Treatment Resistant Disorders | — | UNRESOLVED | — |
| Tumor Progression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sodium selenite | Drug | — | UNRESOLVED |
| Sodium selenite (Introselen) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Selenite treatment
- description
- In the first part of the study, cohorts of 3 patients receive sodium selenite iv, starting with a dose of 0.5 mg/m2. If no serious adverse event the next cohort is treated according to a dose escalation schedule and this part has been completed. In the modified protocol, a continuous infusion over 2 days will be administered.
- interventionNames
- Drug: Sodium selenite (Introselen)
- Drug: Sodium selenite
Primary outcomes (1)
- measure
- Maximal tolerable dose (phase I, ongoing)
- timeFrame
- within three year
- description
- To find which kind and grade of toxicities that are dose-limiting
Secondary outcomes (1)
- measure
- Responses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available