Lithium for Low-Grade Neuroendocrine Tumors

NCT00501540 | Completed Phase 2 Results DMC

• 6 other identifiers: CO07203R21CA117117-01A2H-2007-0065NCI-2011-00616A534260SMPH\MEDICINE\HEM-ONC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuroendocrine Tumors

Keywords

low-grade neuroendocrine tumors; lithium

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 4 years

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  Up to 4 years

• Overall Survival (OS)

  Up to 4 years

Study Arms (1)

Lithium

EXPERIMENTAL

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.

Drug: Lithium Carbonate

Interventions

Lithium Carbonate DRUG

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.

Lithium

Eligibility Criteria

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

You may qualify if:

• Must have histologically confirmed metastatic low-grade neuroendocrine neoplasms. Small cell lung cancers, paragangliomas and pheochromocytomas are excluded. Pathologic diagnosis must be confirmed at the University of Wisconsin Carbone Cancer Center (UWCCC). Grading must be confirmed by pathologic review performed at UWCCC.
• Must have measurable disease
• Must have radiographic evidence of disease progression following any prior systemic therapy, chemoembolization, bland embolization, surgery, or observation.
• Must be ≥ 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration
• Must be ≥ 3 weeks from the completion of radiation therapy to study registration
• The following laboratory values are to be obtained within 14 days prior to registration: Absolute neutrophils count (ANC) ≥ 1000/mm3; Platelets ≥ 75,000/mm3; Hemoglobin ≥ 8.0 g/dL; Total bilirubin less than or equal 2.0 X the upper limit of normal (ULN); AST less than or equal to 3 X ULN or less than or equal 5 X ULN if liver metastases are present; Creatinine less than or equal ULN; Serum sodium within normal limits
• PS = 0-2
• Capable of understanding the investigational nature, potential risks and benefits fo the study and able to provide valid informed consent.
• Must have available tissue specimens to be analyzed for pathologic confirmation.
• Age ≥ 18 years.
• Women must not be pregnant or lactating.
• Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception.
• Patients must not have known history of allergic reactions or adverse reactions to Lithium or derivatives.
• Patients are not allowed to be on concurrent chemotherapy or radiation therapy.
• Patients are excluded if they have any of the following:

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Lubner SJ, Kunnimalaiyaan M, Holen KD, Ning L, Ndiaye M, Loconte NK, Mulkerin DL, Schelman WR, Chen H. A preclinical and clinical study of lithium in low-grade neuroendocrine tumors. Oncologist. 2011;16(4):452-7. doi: 10.1634/theoncologist.2010-0323. Epub 2011 Mar 10.

  PMID: 21393344 RESULT

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Results Point of Contact

• Title: Dr. Noelle LoConte
• Organization: University of Wisconsin Carbone Cancer Center

ns3@medicine.wisc.edu

608-265-5883

Study Officials

• Noelle LoConte, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Herbert Chen, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 16, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 26, 2019
• Results First Posted: May 3, 2017

Record last verified: 2017-03

Locations

US (1)