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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: | NCT00616642 |
RATIONALE: Rosiglitazone may help pituitary adenoma cells become more like normal cells, and grow and spread more slowly.
PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed or residual or recurrent pituitary adenoma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: rosiglitazone maleate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Rosiglitazone (Peroxisome Proliferating Activating Receptor-Gamma {PPAR-y} Ligand) Treatment of Pituitary Tumors |
Estimated Enrollment: | 30 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1 (ACTH-secreting adenomas): Experimental
Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.
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Drug: rosiglitazone maleate
Given orally
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Group 2 (non-secreting macroadenomas): Experimental
Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.
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Drug: rosiglitazone maleate
Given orally
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OBJECTIVES:
OUTLINE: Patients are grouped according to adrenocorticotropic hormone (ACTH)-secreting status (yes [Group 1] vs no [Group 2]).
Patients undergo collection of blood and urine samples at baseline and after completion of study therapy to assess pituitary function, thyroid function, and 24-hour urinary free cortisol levels. Additional assessments include corticotrophin-stimulation testing, dynamic pituitary function testing (i.e., arginine/growth-hormone releasing-hormone testing) to measure growth hormone secretion, and overnight 1 mg dexamethasone suppression testing to measure 8 a.m. serum cortisol levels. Patients also undergo MRI at baseline and after completion of study therapy to examine the effects of rosiglitazone maleate treatment on pituitary tumor size.
Patients complete a questionnaire at baseline and monthly during study for evaluation of headaches.
PROJECTED ACCRUAL: A total of 15 patients with ACTH-secreting pituitary tumor and 15 patients with non-secreting pituitary macroadenomas will be accrued for this study.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically demonstrable pituitary tumor, including either of the following subtypes:
ACTH-secreting adenoma
Clinically demonstrable tumor, as evidenced by both of the following:
Non-secreting pituitary adenoma
Newly diagnosed disease or residual tumor after prior surgical debulking
No biochemical evidence of any of the following:
Hypopituitarism allowed as evidenced by any or all of the following:
Patients with Cushing disease (i.e., harboring ACTH-secreting pituitary adenomas) must meet the following criteria:
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: | CDR0000586480, UCLA-0411082-03 |
Study First Received: | February 14, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00616642 |
Health Authority: | Unspecified |
recurrent pituitary tumor ACTH-producing pituitary tumor nonfunctioning pituitary tumor |
Hypothalamic Diseases Pituitary Diseases Central Nervous System Diseases Endocrine System Diseases Central Nervous System Neoplasms Pituitary Neoplasms Brain Diseases |
Supratentorial Neoplasms Recurrence Brain Neoplasms Endocrinopathy Rosiglitazone Nervous System Neoplasms Endocrine Gland Neoplasms |
Neoplasms Hypoglycemic Agents Neoplasms by Site Hypothalamic Neoplasms |
Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |