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

This study has been terminated.
(Insufficient recruits)
Sponsor:
Collaborators:
Deakin University
Peter MacCallum Cancer Centre, Australia
Information provided by (Responsible Party):
Barwon Health
ClinicalTrials.gov Identifier:
NCT01486459
First received: December 4, 2011
Last updated: August 14, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention
Small Cell Lung Cancer
Drug: Lithium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Barwon Health:

Primary Outcome Measures:
  • Feasibility of a project design where the patients are randomized into lithium or placebo [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events


Secondary Outcome Measures:
  • Neurocognition [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measurements of CogState, Cognitive Failures Questionnaire, CES-D and somnolence syndrome using the Epworth Sleepiness Scale in patients treated with lithium compared to the controls


Enrollment: 7
Study Start Date: November 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI with lithium
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
250 mg daily for 6 weeks, increased 250 - 500 mg depending on plasma levels.
Other Name: Lithicarb
No Intervention: Standard
Prophylactic cranial irradiation alone.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486459

Locations
Australia, Victoria
Barwon Health
Geelong, Victoria, Australia, 3220
Peter MacCallum Cancer Centre
Moorabbin, Victoria, Australia, 3189
Sponsors and Collaborators
Barwon Health
Deakin University
Peter MacCallum Cancer Centre, Australia
Investigators
Principal Investigator: Mustafa Khasraw, MD Barwon Health
  More Information

No publications provided

Responsible Party: Barwon Health
ClinicalTrials.gov Identifier: NCT01486459     History of Changes
Other Study ID Numbers: ALCC 11.01
Study First Received: December 4, 2011
Last Updated: August 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lithium
Lithium Carbonate
Neuroprotective Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014