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

NCT01486459 | Terminated

• 1 other identifier: ALCC 11.01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of a project design where the patients are randomized into lithium or placebo

  Number of participants with adverse events

  1 year

Secondary Outcomes (1)

• Neurocognition

  1 year

Study Arms (2)

PCI with lithium

EXPERIMENTAL

Prophylactic cranial irradiation Lithicarb® tablets 250mg/day for 6 weeks. Initial dosing will be 250mg given once daily, and increased by 250 - 500 mg increments depending on plasma levels.

Drug: Lithium

Standard

NO INTERVENTION

Prophylactic cranial irradiation alone.

Interventions

Lithium DRUG

250 mg daily for 6 weeks, increased 250 - 500 mg depending on plasma levels.

Also known as: Lithicarb

PCI with lithium

Eligibility Criteria

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

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barwon Health: lead
• Deakin University: collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator

Study Sites (2)

Barwon Health

Geelong, Victoria, 3220, Australia

Location

Peter MacCallum Cancer Centre

Moorabbin, Victoria, 3189, Australia

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Lithium

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Mustafa Khasraw, MD

  Barwon Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2011
• First Posted: December 6, 2011
• Study Start: November 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 18, 2015

Record last verified: 2013-08

Locations

AU (2)