Overview

Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis

Status:
Terminated
Trial end date:
2016-06-08
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kathy Miller
Treatments:
Guanabenz
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).