Preoperative Bexarotene Treatment for Cushing's Disease

NCT00845351 | Unknown Phase 1

• 1 other identifier: 13936
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is to establish the safety and tolerability of short-term therapy with bexarotene in patient's with Cushing's disease, and study the clinical, biochemical, and cellular effects of a preoperative five-day course of bexarotene in these patients before undergoing transsphenoidal surgery.

Conditions

Cushing's Disease

Keywords

Cushing's

Outcome Measures

Primary Outcomes (3)

• diurnal plasma ACTH

  Days 1- 5

• cortisol levels

  Days 1-5

• Adverse events

  Days 1-5 and day two post-op

Secondary Outcomes (1)

• clinical outcomes

  Day 1-5, then at month 6 and 12, then every 12 months

Study Arms (1)

Bexarotene

EXPERIMENTAL

Bexarotene 300 mg/m2/day times 5 days

Drug: Bexarotene

Interventions

Bexarotene DRUG

bexarotene at 300 mg/m2/day

Bexarotene

Eligibility Criteria

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

You may qualify if:

• Age 18-65
• Clinical and biochemical diagnosis of Cushing's disease as established by clinical history, physical exam, and definitive biochemical testing:
• Persistent hypercortisolemia established by 24 hour urine free cortisol measurements
• Confirmation of pituitary-dependent hypercortisolemia 1. ACTH levels normal or elevated, and if clinically necessary, one of the following:
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• Suppression of 24 hour urine free cortisol with either the 48-hour dexamethasone suppression test, or suppression of serum cortisol after an overnight high-dose (8 mg) dexamethasone suppression test -OR-
• Inferior Petrosal Sinus Sampling (IPSS) study
• Pituitary MRI performed within three months of enrollment
• Health status deemed appropriate for transsphenoidal surgery by the neurosurgical preoperative evaluation at the University of Virginia Pituitary Clinic

You may not qualify if:

• Age less than 18 or greater than 65
• Pregnant or nursing mothers
• Previous surgical, medical, or radiation therapy involving the pituitary fossa
• History of malignancy, solid or hematogenous
• History of intracranial disease, injury or intracranial surgical procedure
• Renal impairment with a GFR estimated at \< 60 mL/min/1.73 m2
• History of liver disease, or baseline liver transaminase levels \>50% above the upper limit of normal
• Fasting Triglycerides \> 200 mg/dL
• History of pancreatitis
• Pituitary macroadenoma (\> 1 cm) as measured by MRI performed within 3 months of enrollment
• Previous treatment for Cushing's disease including surgery, radiation, or medical therapy:
• Ketoconazole
• Metyrapone
• Aminoglutethimide
• Mitotane

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Mary Lee Vance, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary Bush, MD

CONTACT

434-924-2284; zmb8e@virginia.edu

Mary Lee Vance, MD

CONTACT

434-924-2284; mlv@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: November 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 30, 2011

Record last verified: 2011-05

Locations

US (1)