Rosiglitazone in Treating Patients With Pituitary Tumors (NCT00616642) | Clinical Trial Compass
TerminatedPhase 2
Rosiglitazone in Treating Patients With Pituitary Tumors
Stopped: low patient recruitment
United States1 participantsStarted 2006-10
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinically demonstrable pituitary tumor, including either of the following subtypes:
* ACTH-secreting adenoma
* Residual or recurrent disease ≥ 1 month after prior pituitary surgery
* Clinically demonstrable tumor, as evidenced by both of the following:
* Elevated 24-hour urinary free cortisol (UFC) level
* Lack of suppression of 8 a.m. serum cortisol to \< 1.8 µg/dL after administration of dexamethasone 1 mg at 11 p.m. the previous night
* Tumor demonstrated by MRI performed with and without contrast and/or by inferior petrosal sinus sampling with evidence of a central ACTH source.
* Normal visual field evaluation by Goldman perimetry
* Hypopituitarism allowed as evidenced by any or all of the following:
* Subnormal growth hormone (GH) response to arginine/GH-releasing hormone testing (normal response is an increase of 2-6 ng/me)
* Low age and sex-matched IGF-1 levels
* Low thyroid-stimulating hormone, free triiodothyronine, and free thyroxine levels
* Low estradiol levels
* Low leuteinizing hormone (LH) and low follicle-stimulating hormone (FSH) levels in post-menopausal female patients OR low testosterone, LH, and FSH levels in male patients
* Patients with Cushing disease (i.e., harboring ACTH-secreting pituitary adenomas) must meet the following criteria:
* Hypercortisolemic (i.e., uncured) despite ≥ 1 pituitary surgery
* Refuse to undergo pituitary irradiation and/or bilateral adrenalectomy
* Refuse alternate steroid-lowering therapy…
What they're measuring
1
Efficacy of Rosiglitazone Maleate on Cushing Disease