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Neuroprotective Effects of Lithium in Patients With Small Cell Lung Cancer Undergoing Radiation Therapy to the Brain

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Carcinoma

Intervention: Lithium Carbonate (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Clifford Robinson, M.D., Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
Clifford Robinson, M.D., Phone: 314-362-4633, Email: crobinson@radonc.wustl.edu

Summary

This phase I/II trial studies the effects and safety of giving lithium carbonate (lithium) to patients with small cell lung cancer (SCLC) undergoing radiation therapy to the brain (PCI; prophylactic cranial irradiation). PCI is used to prevent cancer metastases from returning in the brain. This treatment can cause short-term memory problems by damaging the hippocampus. Lithium may help prevent or lessen memory problems caused by PCI by protecting the hippocampus.

Clinical Details

Official title: Phase I/II Trial of Lithium as a Neuroprotective Agent for Patients With Small Cell Lung Cancer (SCLC) Treated With Prophylactic Cranial Irradiation (PCI)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

Dose-limiting toxicities of lithium (DLTs), (safety lead-in)

Rate of immediate recall memory deterioration at 3 months, (phase II)

Secondary outcome:

Rate of immediate recall memory deterioration at 6 and 12 months

Rate of delayed recall memory deterioration at 3, 6 and 12 months

Incidence of brain metastases

Overall survival

Changes in quality-of-life following PCI

Change in hippocampal morphology following lithium + PCI

Incidence of adverse events

Feasibility of performing serial neurocognitive testing and quality of life exams in patients wit

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient must have histologically or cytologically confirmed small cell lung cancer.

Patients with either limited or extensive stage disease are eligible.

- Patient must have completed 4-6 cycles of platinum-based chemotherapy (+/- thoracic

radiotherapy).

- Patient must have no evidence of progressive disease on restaging imaging within 3

months of enrollment

- For patients taking medications known to have a significant interaction with lithium

carbonate, these medications should be discontinued at least 1 week prior to and during lithium treatment

- Patient must be > or = 18 years old.

- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of

=< 2

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< 1. 5 x institutional upper limit of normal (IULN)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase

[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3. 0 x IULN

- Creatinine within normal institutional limits OR creatinine clearance >= 50

mL/min/1. 73 m^2 for patients with creatinine levels above institutional normal

- Patient must have an electrocardiogram without evidence of arrhythmia, QT

prolongation (QTc > 450 ms in males and > 470 ms in females), or other severe dysfunction within 2 weeks of initiation of lithium

- Women of childbearing potential (women with regular menses, women with amenorrhea,

women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, and women who have had a tubal ligation) are required to have a negative urine pregnancy test within 14 days prior to the first dose of lithium.

- Women of childbearing potential and men must agree to use adequate contraception

(hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately

- Patient (or legally authorized representative if applicable) must be able to

understand and willing to sign an Internal Review Board (IRB) approved written informed consent document Exclusion Criteria:

- Patient must not have history of prior cranial radiotherapy

- Patient must not have brain metastases present prior to initiation of initial therapy

or PCI

- Patient must not have evidence of progressive disease

- Patient must not have received chemotherapy within 3 weeks of initiation of PCI

- Patient must not have a history of other malignancy =< 2 years previous with the

exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix

- Patient must not be actively receiving any other investigational agents

- Patient must not have a history of allergic reactions attributed to compounds of

similar chemical or biologic composition to lithium carbonate

- Patient must not have any uncontrolled intercurrent illness including, but not

limited to, ongoing or active infection symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

- Patient must not have any uncontrolled thyroid disease

- Patient must not have a seizure disorder

- Patient must not be pregnant and/or breastfeeding

Locations and Contacts

Clifford Robinson, M.D., Phone: 314-362-4633, Email: crobinson@radonc.wustl.edu

Washinton University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Dennis Hallahan, M.D., Sub-Investigator
Dinesh Thotala, Ph.D., Sub-Investigator
Jeffrey Bradley, M.D., Sub-Investigator
Todd DeWees, Ph.D., Sub-Investigator
Tammie Benzinger, M.D., Sub-Investigator
Daniel Marcus, Ph.D., Sub-Investigator
Additional Information

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Starting date: April 2012
Last updated: March 17, 2015

Page last updated: August 23, 2015

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