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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Lithium carbonate + prophylactic cranial irradiation | Experimental | Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI. PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium Carbonate | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of Lithium Carbonate as Measured by Number of Patients in the Safety lead-in Who Experienced a Dose-limiting Toxicity (DLT) | -Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4. Safety will be defined as < 2 patients experiencing DLTs of the first 6 treated. | 3 weeks |
| Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score |
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clifford Robinson, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washinton University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation | Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI. PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Prophylactic cranial irradiation | Radiation |
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| 6 months |
| Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score |
| 12 months |
| Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score |
| 3 months |
| Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score |
| 6 months |
| Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score |
| 12 months |
| Changes in Quality-of-life as Measured by Overall Quality of Life Using the EORTC QLQ30 |
| 3 months |
| Changes in Quality-of-life as Measured by Overall Quality of Life Using the Total Score of the EORTC QLQ-BN20 | Assessed by comparing questionnaire test scores to baseline; BN20 (future uncertainty and communications deficit scales)
| 12 months |
| Feasibility of Performing Serial Neurocognitive Testing and Quality of Life Exams as Measured by Number of Patients Who Complete the Neurocognitive Testing and Quality of Life Exams | -Defined as at least 4 of 6 patients successfully completing pre-treatment and 3 month post-treatment testing | 3 months |
| Change in Hippocampal Morphology Following Lithium + PCI as Measured by Total Hippocampal Volume | Baseline through 12 months |
| Number of Participants With Brain Metastases | 1-year rate of brain metastases | 12 months |
| Number of Central Nervous System (CNS) Adverse Events | Adverse events will be tabulated by type and grade using NCI CTCAE v 4. | Through 12 months |
| Rate of Overall Survival | -Overall survival is defined as the time between date of on study and date of death due to any cause | 12 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation | Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI. PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of Lithium Carbonate as Measured by Number of Patients in the Safety lead-in Who Experienced a Dose-limiting Toxicity (DLT) | -Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4. Safety will be defined as < 2 patients experiencing DLTs of the first 6 treated. | -Only patients enrolled in the safety lead-in were evaluable for this outcome measure | Posted | Count of Participants | Participants | 3 weeks |
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| Primary | Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score |
| 6 participants were not evaluable for this outcome measure | Posted | Mean | Standard Deviation | scores on a scale | 3 months |
|
| ||||||||||||||||||||||||||
| Secondary | Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score |
| 11 participants were not evaluable for this outcome measure | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
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| Secondary | Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score |
| 13 participants were not evaluable for this outcome measure | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
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| ||||||||||||||||||||||||||
| Secondary | Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score |
| -8 participants were not evaluable for this outcome measure | Posted | Mean | Standard Deviation | scores on a scale | 3 months |
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| ||||||||||||||||||||||||||
| Secondary | Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score |
| 11 participants were not evaluable for this outcome measure | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
|
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| Secondary | Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score |
| 13 participants were not evaluable for this outcome measure | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
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| Secondary | Changes in Quality-of-life as Measured by Overall Quality of Life Using the EORTC QLQ30 |
| 5 participants were not analyzed for this outcome measure | Posted | Mean | Standard Deviation | scores on a scale | 3 months |
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| ||||||||||||||||||||||||||
| Secondary | Changes in Quality-of-life as Measured by Overall Quality of Life Using the Total Score of the EORTC QLQ-BN20 | Assessed by comparing questionnaire test scores to baseline; BN20 (future uncertainty and communications deficit scales)
| 5 participants were not evaluable for this outcome measure | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
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| Secondary | Feasibility of Performing Serial Neurocognitive Testing and Quality of Life Exams as Measured by Number of Patients Who Complete the Neurocognitive Testing and Quality of Life Exams | -Defined as at least 4 of 6 patients successfully completing pre-treatment and 3 month post-treatment testing | (1) participant is not evaluable as the participant did not start treatment due to pre-treatment MRI showing metastatic disease in spine. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Change in Hippocampal Morphology Following Lithium + PCI as Measured by Total Hippocampal Volume |
| Posted | Median | Full Range | cc | Baseline through 12 months |
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| Secondary | Number of Participants With Brain Metastases | 1-year rate of brain metastases | 7 participants were not evaluable for this outcome measure | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Central Nervous System (CNS) Adverse Events | Adverse events will be tabulated by type and grade using NCI CTCAE v 4. | Posted | Number | CNS adverse events | Through 12 months |
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| Secondary | Rate of Overall Survival | -Overall survival is defined as the time between date of on study and date of death due to any cause | 7 participants were not evaluable for this outcome measure | Posted | Count of Participants | Participants | 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation | Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI. PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium. | 0 | 19 | 19 | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Red blood cell decrease | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| External ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
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| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Floaters | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Bronchial infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Other - sacroiliac pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Other - right leg pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Other - disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Concentration impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Nystagmus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Other - myoclonic jerk | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clifford Robinson, M.D. | Washington University School of Medicine | 314-362-4653 | clifford.robinson@wustl.edu |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016651 | Lithium Carbonate |
| D008094 | Lithium |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D019565 | Metals, Light |
| D008670 | Metals |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Grade 1 |
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| Grade 2 |
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| Grade 3 |
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