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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00612066 |
Purpose
RATIONALE: Rosiglitazone may help pituitary tumor cells become more like normal cells, and to grow and spread more slowly.
PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: rosiglitazone maleate Other: laboratory biomarker analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosilgitazone Treatment in Patient's With Cushing's Disease |
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral rosiglitazone once daily for 7 weeks in the absence of disease progression or unacceptable toxicity.
Blood, urine, and saliva samples are collected periodically for laboratory studies. Inflammatory markers (C-reactive protein, interleukin-6 [IL-6], serum sialic acid, soluble intracellular and vascular adhesion molecules [sICAM-1, and sVCAM-1], and amyloid A) are measured at baseline and at the completion of study treatment; salivary cortisol and 24-hour urinary-free cortisol levels are measured at baseline and weekly during study treatment; dexamethasone suppression tests with serum cortisol and corticotrophin (CRH) stimulation test are performed at baseline and at the completion of study treatment; prolactin, insulin-like growth factor-1 (IGF1), thyroid function, and sex steroid hormones are measured at baseline and at the completion of study treatment; and dynamic pituitary function testing (arginine/growth hormone-releasing hormone [GHRH] testing to measure growth hormone secretion) is performed at baseline.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically demonstrable ACTH-secreting pituitary tumor
Biochemically active disease that is not adequately controlled, as demonstrated by the following standard criteria:
Patients with evidence of optic nerve or chiasm compression on post-operative MRI must have a normal visual field evaluation by Goldman perimetry
Hypopituitarism* allowed, as evidenced by any or all of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
| Los Angeles, California, United States, 90095-1781 | |
| Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |
| Principal Investigator: | Anthony Heaney, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000586468, UCLA-0612080-01 |
| Study First Received: | February 8, 2008 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00612066 History of Changes |
| Health Authority: | Unspecified |
|
ACTH-producing pituitary tumor |
|
Pituitary Neoplasms Pituitary ACTH Hypersecretion Pituitary Diseases Hypothalamic Diseases Physiological Effects of Drugs Nervous System Diseases Endocrine System Diseases Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Supratentorial Neoplasms |
Pharmacologic Actions Brain Neoplasms Neoplasms Hypoglycemic Agents Hyperpituitarism Neoplasms by Site Hypothalamic Neoplasms Rosiglitazone Nervous System Neoplasms Endocrine Gland Neoplasms |