Study Summary
This trial will study the effects of auranofin and sirolimus on patients with lung cancer.
Eligible Conditions
- Squamous Cell Lung Cancer
- Non-Small Cell Lung Cancer Stage IIIB
- Non-Small Cell Lung Cancer
- Extensive Stage Small Cell Lung Cancer
- Stage IIIA Non Small Cell Lung Cancer
- Lung Adenocarcinoma
- Non Small Cell Lung Cancer
- Small Cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: Up to 5 years
28 days
MTD of auranofin (Phase I)
At 4 months
Progression-free survival rate (Phase II)
Year 5
Change in protein kinase C (PKC) iota protein expression
Year 5
Survival time
Year 5
Progression-free survival time
Up to 5 years
Duration of response
Number and severity of all adverse events (Phase I)
Overall response rate, defined to be either a complete response (CR) or partial response (PR) noted as the objective status
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (auranofin and sirolimus)
1 of 1
Experimental Treatment
47 Total Participants · 1 Treatment Group
Primary Treatment: Pharmacological Study · No Placebo Group · Phase 1 & 2
Treatment (auranofin and sirolimus)Experimental Group · 4 Interventions: Laboratory Biomarker Analysis, Sirolimus, Pharmacological Study, Auranofin · Intervention Types: Other, Drug, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved
Auranofin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,087 Previous Clinical Trials
41,141,659 Total Patients Enrolled
Mayo ClinicLead Sponsor
2,923 Previous Clinical Trials
3,517,166 Total Patients Enrolled
Helen RossPrincipal InvestigatorMayo Clinic
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Hemoglobin (Hgb) > 9 g/dL.
You are of childbearing potential.
You have been treated with radiation therapy before study entry.
You have a platelet count of at least 100,000 uL.
The results of this study do not support the use of age alone as a criterion for initiating treatment in patients with hepatitis C virus-related chronic liver disease.
The diagnosis of lung cancer is supported by histologic or cytologic confirmation of lung cancer.
References
- Rousselle, Benjamin, Aurélie Massot, Malorie Privat, Lucile Dondaine, Audrey Trommenschlager, Florence Bouyer, Jérôme Bayardon, et al.. 2022. “Conception and Evaluation of Fluorescent Phosphine‐gold Complexes: From Synthesis to in Vivo Investigations”. Chemmedchem. Wiley. doi:10.1002/cmdc.202100773.
- 2012. "Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01737502.
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Conditions
Cancer Related
Treatments