Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma | NCT01959438

Studies
Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma

NCT01959438

Sponsor

Karolinska University Hospital

Status

Unknown status

Last Update Posted

Oct 10, 2013Estimated

Enrollment

32Estimated

Phase

Phase 1Phase 2

Conditions

Malignant Tumor
Treatment Resistant Disorders
Tumor Progression

Interventions

Sodium selenite (Introselen)
Sodium selenite

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Oct 2016Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Oct 8, 2013

First Submission Date that Met QC Criteria

Oct 8, 2013

First Posted Date

Oct 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2013

Last Update Posted Date

Oct 10, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ola Brodin, MD, PhD, Ass Prof, Senior consultant, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

Collaborators

Name	Class
Cancerfonden	UNKNOWN
Cancer and Allergy Foundation	UNKNOWN
Cancerföreningen i Stockholm	UNKNOWN
Region Stockholm

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal tolerable dose (phase I, ongoing)	To find which kind and grade of toxicities that are dose-limiting	within three year

Secondary Outcomes

Measure	Description	Time Frame
Responses	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.	Two years within the phase I study

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ola Brodin, MD, PhD	Contact	+46 8 6164344		ola.brodin@karolinska.se

Overall Officials

Name	Affiliation	Role
Ola Brodin, MD, PhD	Karolinska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Onkologkliniken, (Dept of Oncology) Södersjukhuset	Recruiting	Stockholm		11883	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D018450	Disease Progression

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018038	Sodium Selenite

Ancestor Terms

ID	Term
D020887	Selenious Acid
D018036	Selenium Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

Browse Leaves

Not provided

Browse Branches

Not provided