Neoplasms

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Carcinoma

Carcinoma, Neuroendocrine

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Thyroid Cancer, Medullary

Neuroendocrine Tumor

Neuroepithelioma

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Lithium Carbonate

Antidepressive Agents

Enzyme Inhibitors

Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.2; Continue until progressive disease/unacceptable toxicity; Evaluate every 4 weeks.

Lithium carbonate

Herbert Chen, MD

Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate

An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

University of Wisconsin, Madison

Adverse events (AEs) were reported routinely at scheduled times during the trial. Additionally, some adverse events were reported in an expedited manner for more timely monitoring of patient safety and care. The serum lithium level was checked after 4-5 days of treatment by blood sample prior to daily dose 1 of lithium. If lithium level was outside the 0.8-1.2 mmol/L range, lithium levels were monitored weekly for 4 weeks and monthly after 4 weeks.

AEs grades range from 1 (mild) to 5 (death).

Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.

Lithium Capsules

< 50 years of age

50-59 years of age

60-69 years of age

> 69 years of age

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

This study enrolled participants with Medullary Thyroid Cancer (MTC).

Director of Clinical Research

No data was ever analyzed, resulted, or published on this study.

Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)

Overall Study

Nervous System Diseases

Glioma

Brain Neoplasms

Neoplasms, Neuroepithelial

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

Bevacizumab

Temozolomide

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Cycle 1(One 42-day cycle)

* Temozolomide 75 mg/m\^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
* Radiation within 3-5 weeks of surgery
* Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks

Treatment Cycles 2-7 (28 days per cycle)

* Temozolomide at a dose of 150 mg/m\^2 on Days 1-7
* Bevacizumab 10 mg/kg on Day 8 and Day 22
* Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L.

Radiation

Deborah Gruber, MD

This pilot phase II trial studies how well giving temozolomide, bevacizumab, lithium carbonate, and radiation therapy works in treating patients with newly diagnosed high grade glioma.

Treatment of high grade glioma (HGG) with anti-angiogenic therapy results in clinical improvement and prolonged progression-free survival (PFS). However, mant patients experience diffuse recurrence and treatment failure. This is a phase II trial testing the feasibility of adding lithium carbonate, previously shown to have anti-invasive properties in HGG, to bevacizumab and chemoradiation following surgical resection of HGG.

Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma

Temozolomide, Bevacizumab, Lithium and Radiation Treatment for Newly Diagnosed High Grade Glioma: A Phase II Study

PFS defined as time from date of diagnosis to most recent follow up, disease progression, or death. Disease progress defined as either clinical deterioration or radiographic progressive disease on magnetic resonance imaging (MRI) per updated response assessment in neuro-oncology criteria (Wen, et al).

OS defined as time from diagnosis to most recent follow up or death.

Genentech, Inc.

Atlantic Health System

NYU Langone Health

TBL/RT

Age, Continuous

Caucasian

Asian

Hispanic

Race/Ethnicity, Customized

Grade III

Grade IV

Grade III: Malignant although there is not always a big difference between grade II and grade III tumors. The cells of a grade III tumor are actively reproducing abnormal cells, which grow into nearby normal brain tissue. These tumors tend to recur, often as a grade IV.

Grade IV: These are the most malignant tumors. They reproduce rapidly, can have a bizarre appearance when viewed under the microscope, and easily grow into nearby normal brain tissue. These tumors form new blood vessels so they can maintain their rapid growth.

World Health Organization Grade (staging)

Michael Gruber, MD

Median Progression-Free Survival (PFS)

Median Overall Survival (OS)

Dermatitis

Neurologic

Pneumonia

Rash

Cough

Hyponatremia

Gastrointestinal

Febril Neutropenia

Neutropenia

Thrombocytopenia

Somnolence

Grade 3

Grade 4

Number of Patients With Grade 3 or 4 Adverse Events

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Androgens

Oral lithium carbonate dose escalation: Level 1 of 600 mg/day, then escalating to Level 2 of 900 mg/day, then the final Level 3 of 1200 mg/day.

Moben Mirza, MD

Laboratory testing has suggested that lithium may decrease the incidence of certain types of cancer, including prostate cancer. Additional research has suggested that lithium decreases prostate cancer tumor size over time. This study will investigate the effect of lithium on men with prostate cancer.

As lithium has been shown in an in vitro model to suppress cellular proliferation, and suppress tumor growth in an in vivo xenograft model, we propose to determine its effect on prostate cancer cells in human patients undergoing radical prostatectomy. In this pilot study we plan to assess the toxicity of lithium administration in patients prior to radical prostatectomy. This will include any clinical toxicity as well as any increase in intra-, peri- or postoperative complications.

Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer

Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.

To evaluate tumor response by lithium concentration in the surgically removed prostate and serum PSA levels.

To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer.

To document observed levels of lithium in the serum

University of Kansas Medical Center

Anti-Infective Agents

Trichostatin A

Lithium carbonate will be dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate will be provided as a 300mg tablet and will be taken daily without breaks in treatment.

Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate will be administered the first week at 300 mg flat dose three times each day. A serum lithium level will be checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluate every 8 weeks.

Noelle LoConte, MD

The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors.

Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.0; Continue until progressive disease/unacceptable toxicity;Evaluate q 8 weeks.

Lithium for Low-Grade Neuroendocrine Tumors

A Phase II Clinical and Biological Study of Lithium Carbonate in Patients With Low-Grade Neuroendocrine Tumors

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), small changes that do not meet the above criteria.

Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival is measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression. If a participant did not experience an event of disease progression or death at the time of analysis (03/10/2011), then the patient's data was censored at the date of the last available evaluation.

Overall survival for a participant is defined as the number of days from the day of first Lithium administration to the participant's death. As of the time of analysis (03/10/2011), median overall survival duration was not reached.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.

Lithium

Age, Categorical

Participants with histologically confirmed metastatic low-grade neuroendocrine neoplasms were enrolled.

Dr. Noelle LoConte

Complete Response (CR)

Partial Response (PR)

Progressive Disease (PD)

Stable Disease (SD)

Progression Free Survival (PFS)

Overall Survival (OS)

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Breast Neoplasms

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

will receive chemotherapy regimen with placebo

will receive chemotherapy regimen with Lithium Carbonate in controlled release formula (400mg b.i.d).

In order to avoid the potential for bone marrow stimulation at the time chemotherapy was administered, the administration of lithium was started 24 hours after the administration of chemotherapy and continued for 18 days of every 21.the lithium serum level will be measured at specific times to ensure lithium serum level between 0.4-0.8 mmol\\L along the treatment course.

400 mg tablet in controlled released formula

Using Lithium Carbonate to decrease incidence of neutropenia caused by using chemotherapy regimen in breast cancer patients.

Introduction:

Cytotoxic chemotherapy predictably suppresses the hematopoietic system, impairing host protective mechanisms. Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting the doses of chemotherapy that can be tolerated. The degree and duration of the neutropenia determine the risk of infection. The Common Toxicity Criteria of the National Cancer Institute is the most commonly used scale for grading the severity of the cytopenias associated with cancer chemotherapy; it delineates neutropenia into 4 grades. Chemotherapy predisposes patients with cancer to infections both by suppressing the production of neutrophils and by cytotoxic effects on the cells that line the alimentary tract. Neutrophils are the first line of defence against infection as the first cellular component of the inflammatory response and a key component of innate immunity. Neutropenia blunts the inflammatory response to nascent infections, allowing bacterial multiplication and invasion. Because neutropenia reduces the signs and symptoms of infection, patients with neutropenia often may present with fever as the only sign of infection. In this setting, patients with fever and neutropenia, or febrile neutropenia (FN), must be treated aggressively, typically with intravenous antibiotics and hospitalization, because of the risk of death from rapidly spreading infection. The availability of hematopoietic growth factors and improvements in antibiotic therapy have changed greatly how clinicians approach the management of neutropenia, yet this complication remains a central concern in the delivery of cancer chemotherapy.

Lithium carbonate continues to be the most useful agent available for the prophylaxis and treatment of bipolar illness. Lithium augmentation of antidepressants is useful in the treatment of resistant unipolar depression. Its utility in other psychiatric disorders such as schizophrenia, alcoholism, or aggressive behaviour is documented only when a significant affective component exists. Hematologic changes have been associated with lithium Unexplained increases in white blood cell (WBC) counts have occurred in psychiatric patients treated with lithium. This leukocytosis occurs within 1 week of treatment and is reversible. It is unrelated to age, sex, or diagnosis. Although serum levels above 0.5 milliequivalent/L are required for the effect, there is no proportional response to dose. In 1998, Ballin et al prospectively examined eight adult patients with bipolar disorder to find whether lithium carbonate increased their peripheral blood cluster of differentiation 34 (CD34) hematopoietic stem cells (HSC). The administration of lithium salts to haematologically normal subjects is associated with increased marrow neutrophil production and enhanced release of granulocyte colony stimulating factor (G-CSF) in vitro, followed by peripheral blood neutrophilia.The unsaturated vitamin B12-binding capacity, an indirect assessment of the total-body granulocyte pool, is elevated in patients taking lithium for manic-depressive psychosis. In man, oral lithium carbonate raises urinary levels of G-CSF and augments production of G-CSF by peripheral blood mononucleated cell. Moreover, when Levitt and Quesenberry studied the effects of adding lithium to a murine bone marrow liquid culture system, lithium substantially increased the number of granulocyte-committed progenitor cells and pluripotential stem cells. Lithium therefore seems to have at least two distinct actions in haematopoiesis: It enhances the production of G-CSF, and it directly stimulates the proliferation of pluripotential stem cells. In 1978, Stein et al. first formally showed that lithium-induced granulocytosis was not merely a redistribution of granulocytes that are marginated or are in the marrow reserves, supporting the hypothesis of increased granulocyte production. Lithium also affects cytokines that involved in mobilization of neutrophils from bone marrow to blood through inhibition of Glycogen synthase kinase 3 (GSK-3) function, thereby indirectly increasing the attractive CXCL12 gradient toward a hypoxic marrow trophic niche, where HSCs can thrive. This is reflected by increased marrow trophic niche function: peripheral neutrophilia, increased platelets, and increased CD34+ counts.

Additionally, lithium has anticancer activity and neuroprotective properties. One piece of experimental evidence for lithium's potential as a cancer therapy is that inhibition of GSK3 was observed to inhibit prostate cancer cell proliferation. With respect to colorectal cancer, it has been found that lithium inhibits proliferation of a colorectal cancer cell line. Phosphatase and tensin homolog (PTEN) overexpression and lithium administration were shown to cooperatively inhibit proliferation of colorectal cancer cells. Because lithium therapy is systemic rather than topical or local, it follows that lithium might inhibit metastasis. Evidence that this is the case for colon cancer comes from observation of inhibition of metastasis-inducing factors by lithium and by observation on reduced metastasis in model animals given lithium therapy. Autophagy is a key cellular process in the inhibition of cancer. Lithium has been shown to induce autophagy, due to its inhibition of inositol monophosphatase.

For these issues that mentioned above about neutropenia and lithium ability to reduce the incidence of neutropenia in patient taking chemotherapy without needing to highly costing recombinant granulocyte colony stimulating factors that Egyptian patient can't afford or using the antibiotic as a prophylactic agent that will result in resistance. we want to use lithium to attenuate neutropenia induced chemotherapy. Also because of the anti-cancer activity and neuroprotective properties of lithium that mentioned above we hypothesis that lithium will not conflict with chemotherapy treatment but will help to gain the maximum benefit of chemotherapy and minimize the side effects.

Hypothesis:

Because of the effect of lithium on WBCs and its ability to produce leukocytosis,it is hypothesized that lithium is capable of reversing the chemotherapy induced neutropenia, might be through induction of endogenous colony stimulating factor (CSF) or through alteration of the balance between cytokines that involved in neutrophils mobilization from bone marrow to the blood (CXCl12 and CXCl1).

Aim:

To investigate the efficacy of lithium carbonate in attenuating chemotherapy induced neutropenia, the effect of lithium on granulocyte colony stimulating factor and cytokines involved in neutrophils mobilization from bone marrow to blood in breast cancer patients

Patients and methodology:

This is a prospective randomized study include (50 patients) will be done in collaboration between Clinical Pharmacy Department, Faculty of Pharmacy, Al-Azhar University, Cairo and Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Tanta University during June/2020 to June/2021 in breast cancer patients received chemotherapy which induced neutropenia.

Efficacy of Lithium Against Chemotherapy Induced Neutropenia in Breast Cancer Patients

Evaluation of Lithium Efficacy Against Chemotherapy Induced Neutropenia in Breast Cancer Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Initial Study of Lithium in Patients With Medullary Thyroid Cancer	NCT00582712	Medullary Thyro...	Lithium carbona...	18 Years -	University of Wisconsin, Madison
Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma	NCT01105702	Brain Cancer	Temozolomide Bevacizumab Lithium Carbona... Radiation	18 Years -	NYU Langone Health
Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer	NCT02198859	Prostate Cancer	Lithium Carbona...	18 Years -	University of Kansas Medical Center
Lithium for Low-Grade Neuroendocrine Tumors	NCT00501540	Neuroendocrine ...	Lithium Carbona...	18 Years -	University of Wisconsin, Madison
Efficacy of Lithium Against Chemotherapy Induced Neutropenia in Breast Cancer Patients	NCT05221593	Neutropenia	Lithium Carbona...	-	Al-Azhar University
Efficacy of Lithium Against Chemotherapy Induced Neutropenia in Breast Cancer Patients	NCT05221593	Neutropenia	Lithium Carbona...	-	Al-Azhar University
The CHAMP-study: The CHemopreventive Effect of Lithium in Familial AdenoMatous Polyposis	NCT05402891	Familial Adenom...	Lithium Carbona...	18 Years - 35 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia	NCT01820624	Adult Acute Meg... Adult Acute Mon... Adult Acute Mon... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Erythrole... Adult Pure Eryt... Recurrent Adult...	tretinoin lithium carbona... laboratory biom...	18 Years -	Case Comprehensive Cancer Center
Lithium for Low-Grade Neuroendocrine Tumors	NCT00501540	Neuroendocrine ...	Lithium Carbona...	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for lithium carbonate