A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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 tumour. It is now part of care to also offer Prophylactic Cranial Irradiation (PCI) in order to prevent spread of the cancer into the brain.

Cognitive impairment can result after cranial irradiation. Lithium is thought to be neuroprotective. It is hypothesized that lithium administration with PCI will be safe, tolerable and feasible, and can be studied to prevent or ameliorate the ensuing cognitive impairment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barwon Health
• Collaborators: Deakin University; Peter MacCallum Cancer Centre, Australia
• Treatments: Lithium Carbonate; Neuroprotective Agents

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.