Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma

NCT01959438 | Unknown Phase 1 DMC

• 1 other identifier: Eu-nr 2006-004076-13
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 1.Phase I: Find maximal tolerable dose with continuous infusion
2. 2.Phase II: Use MTD and study responses, if any

Conditions

Malignant Tumor; Treatment Resistant Disorders; Tumor Progression

Keywords

Phase I study for safety; Later Phase II study for responses

Outcome Measures

Primary Outcomes (1)

• Maximal tolerable dose (phase I, ongoing)

  To find which kind and grade of toxicities that are dose-limiting

  within three year

Secondary Outcomes (1)

• Responses

  Two years within the phase I study

Study Arms (1)

Selenite treatment

EXPERIMENTAL

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.

Drug: Sodium selenite (Introselen); Drug: Sodium selenite

Interventions

Sodium selenite (Introselen) DRUG

Intravenous infusion daily for each week day during 2 weeks (10 infusions). After that chemotherapy during 6 weeks. Chemotherapy for each patients is the first line treatment, so chemotherapy differs among patients, with respect to which treatment a patient got as first line.

Also known as: Introselen (Pharma Nord)

Selenite treatment

Sodium selenite DRUG

Intravenous treatment as described above. Cohorts of 3 patient are given a fixed dose for daily treatment (started with 0.5 mg/m2) and if no grade 3 or 4 toxicity, a new cohort is started on a higher dose. The dose for next cohort is 50% higher than for the former cohort. If grade 3 or 4 toxicity is found in 1 patient, 3 more patients are included on the same dose and if one more patient has serious toxicity it is considered to high a dose and a dose in between the toxic dose and the one before is tested. Thus if 2 patients in 3-6 tested patients has serious toxicity by a certain dose, this dose is to high and the highest dose is considered the earlier tested dose.

Also known as: Introselen (Pharma Nord)

Selenite treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Cancerfonden: collaborator
• Cancer and Allergy Foundation: collaborator
• Cancerföreningen i Stockholm: collaborator
• Region Stockholm: collaborator

Study Sites (1)

Onkologkliniken, (Dept of Oncology) Södersjukhuset

Stockholm, 11883, Sweden

RECRUITING

MeSH Terms

Conditions

Neoplasms; Disease Progression

Interventions

Sodium Selenite

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Selenious Acid; Selenium Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ola Brodin, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ola Brodin, MD, PhD

CONTACT

+46 8 6164344; ola.brodin@karolinska.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Ass Prof, Senior consultant

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: February 1, 2007
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2018
• Last Updated: October 10, 2013

Record last verified: 2013-10

Locations

SE (1)