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Trial record 44 of 4291 for:    bone tumors AND NOT metastatic

Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02443103
Recruitment Status : Terminated (Slow accrual)
First Posted : May 13, 2015
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Kathy Miller, Indiana University School of Medicine

Brief Summary:
This study will explore the biologic activity of guanabenz in reducing bone turn over in solid tumor patients with bone metastasis. If successful, this repurposing of an already, generic drug could benefit patients faster than manufacturing a novel expensive compound.

Condition or disease Intervention/treatment Phase
Bone Cancer Metastasis Drug: Guanabenz acetate Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Pilot Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis
Actual Study Start Date : May 7, 2015
Actual Primary Completion Date : June 8, 2016
Actual Study Completion Date : June 8, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Guanabenz Drug: Guanabenz acetate



Primary Outcome Measures :
  1. Bone Turnover Markers-bone Formation and Bone Resorption [ Time Frame: Day 0, Week 8, Week 12 ]
    Number of patients who had blood specimens taken to collect and evaluate markers of bone formation and bone resorption. Note - due to poor accrual and early closure, bone marker data was not collected.


Secondary Outcome Measures :
  1. Treatment Related Adverse Events [ Time Frame: Up to 1 year ]
    Number of unique patients who had a treatment related (possible, probable or definite) adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 18 years old at the time of informed consent
  2. Ability to provide written informed consent and HIPAA authorization
  3. Solid organ malignancy with documented bone metastasis by imaging
  4. Adequate liver function (serum total bilirubin <= 3 and AST/ALT <= 3 times the upper normal limit)
  5. Adequate renal function (serum creatinine <= 2mg/dL)
  6. Ability to swallow oral tablets
  7. Females of childbearing potential must have a negative pregnancy test <= 28 days prior to registration. All females of childbearing potential who are sexually active, must agree to use a highly reliable method of contraception to prevent pregnancy. These include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).

    NOTE: Females are considered of childbearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (> 12 months since last menses).

  8. Patients are permitted to participate in other clinical trials while participating in this trial.
  9. Patients will receive standard of care systemic treatment for underlying solid malignancy as deemed necessary by treating physician.

Exclusion Criteria:

  1. No prior history of bisphosphonate ordenosumab use in the past 12 months
  2. No history of SRE within past 3 months

    1. Excruciating bone pain requiring RT
    2. Cord compression
    3. Hypercalcemia [serum calcium >10.5]
    4. Pathologic fracture
  3. No history of Paget's disease
  4. No history of epilepsy/seizures
  5. No history of hypotension (defined as resting systolic blood pressure of < 110 mm Hg or diastolic blood pressure of < 70 mm Hg) or orthostasis (defined as drop in systolic blood pressure of >20 mm Hg or increase in HR of > 20 from supine to standing position).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443103


Locations
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United States, Indiana
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Spring Mill Medical Center
Indianapolis, Indiana, United States, 46290
Sponsors and Collaborators
Kathy Miller
Investigators
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Principal Investigator: Kathy Miller, MD Indiana University (IU) School of Medicine, Department of Medicine; IU Health

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Responsible Party: Kathy Miller, Full Professor of Medicine and Sheila D. Ward Scholar, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT02443103     History of Changes
Other Study ID Numbers: IUCRO-0506
First Posted: May 13, 2015    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018
Last Verified: February 2018

Keywords provided by Kathy Miller, Indiana University School of Medicine:
pilot study
guanabenz acetate

Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Neoplasms
Neoplasms by Site
Bone Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Osteosarcoma
Neoplastic Processes
Pathologic Processes
Musculoskeletal Diseases
Sarcoma
Guanabenz
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs