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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00612066 |
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 |
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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.
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:
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 |
Study ID Numbers: | CDR0000586468, UCLA-0612080-01 |
Study First Received: | February 8, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00612066 History of Changes |
Health Authority: | Unspecified |
ACTH-producing pituitary tumor |
Hypothalamic Diseases Pituitary Diseases Cushing Syndrome Central Nervous System Diseases Endocrine System Diseases Central Nervous System Neoplasms Pituitary Neoplasms Brain Diseases |
Supratentorial Neoplasms Pituitary ACTH Hypersecretion Brain Neoplasms Hypoglycemic Agents Endocrinopathy Rosiglitazone Nervous System Neoplasms Endocrine Gland Neoplasms |
Hypothalamic Diseases Pituitary Diseases Physiological Effects of Drugs Nervous System Diseases Endocrine System Diseases Central Nervous System Diseases Pituitary Neoplasms Central Nervous System Neoplasms Brain Diseases Supratentorial Neoplasms Pharmacologic Actions |
Pituitary ACTH Hypersecretion Brain Neoplasms Neoplasms Hypoglycemic Agents Hyperpituitarism Neoplasms by Site Hypothalamic Neoplasms Rosiglitazone Nervous System Neoplasms Endocrine Gland Neoplasms |