Status:
TERMINATED
A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer
Lead Sponsor:
Barwon Health
Collaborating Sponsors:
Deakin University
Peter MacCallum Cancer Centre, Australia
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Small cell lung cancer is an aggressive neuroendocrine tumour that often presents with extensive (metastatic) disease. Chemotherapy is the mainstay of treatment, with radiotherapy to the primary tumou...
Detailed Description
Small cell lung cancer (SCLC) is an aggressive neuroendocrine tumour that often presents with extensive (metastatic) disease.\[1\] It frequently has micrometastatic disease at presentation. Chemothera...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed high grade small cell neuroendocrine carcinoma.
- Patients can either have:
- Limited stage disease with CR or PR OR
- Extensive stage disease with CR or good PR
- Patients must have discontinued other chemotherapies at least 3 weeks prior to randomisation.
- Prior radiation therapy to the chest is allowed but must be completed at least 3 weeks prior to randomisation.
- ECOG Performance Status 0 to 2.
- Adequate bone marrow, liver, and renal function as assessed by the following:
- Hemoglobin ≥ 9.0 g/dl
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Total bilirubin ≤ 2.0 times the upper limit of normal
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (≤ 5x ULN for patients with liver involvement)
- International Normalized Ratio for Prothrombin Time (PT-INR) ≤ 1.5 and activated partial prothrombin time (aPTT) within 5% of normal limits for patient NOT on anticoagulation.
- Estimated Glomerular Filtration Rate (eGRF) \> 50 ml/min .
- Male or female aged \>18 years
- Patients must be able and willing to sign a written informed consent. A signed informed consent must be appropriately obtained prior to any study specific procedures.
- Patients must be able to swallow and retain oral medication.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomisation and must agree to use adequate contraception prior to randomisation and for the duration of study participation.
Exclusion
- Life expectancy less than 3 months.
- Substance abuse, medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.
- Severe cardiac or renal disease.
- Frank hypothyroidism.
- Hyponatraemia.
- Known or suspected allergy to lithium.
- Women who are pregnant or breast-feeding.
- Inability to comply with protocol and /or not willing or not available for follow-up assessments.
- Significant psychiatric or neurologic illness (prior known psych/cognitive/CNS pathology eg CVA; known or prior brain metastases
- Current lithium therapy.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01486459
Start Date
November 1 2012
End Date
September 1 2014
Last Update
March 18 2015
Active Locations (2)
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1
Barwon Health
Geelong, Victoria, Australia, 3220
2
Peter MacCallum Cancer Centre
Moorabbin, Victoria, Australia, 3189