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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Rosiglitazone in Treating Patients With Pituitary Tumors

NCTNCT00616642 (opens ClinicalTrials.gov in a new tab)Other idCDR0000586480Other idUCLA-0411082-03

Overview

Status
Terminated
Phase
Phase 2
Enrollment
1 participants (actual)
Sponsor
Jonsson Comprehensive Cancer Center · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2006
Primary completion
Nov 2010
Completion
Nov 2010
First posted
15 Feb 2008 (estimated)
Last update posted
14 Aug 2020
Conditions
Brain and Central Nervous System Tumors

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008200920102011
  1. Ph 2

    Rosiglitazone in Treating Patients With Pituitary Tumors

    NCT00616642

    Oct 2006 to Nov 2010

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • rosiglitazone maleateDrug

Arms2

  • Experimental

    Group 1 (ACTH-secreting adenomas)

    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.

  • Experimental

    Group 2 (non-secreting macroadenomas)

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Efficacy of Rosiglitazone Maleate on Cushing Disease

    Time frame · 12 months

    Registry description

    Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 12 months

Efficacy of Rosiglitazone Maleate on Cushing Disease

GroupValue
Group 1 (ACTH-secreting Adenomas)not posted
Group 2 (Non-secreting Macroadenomas)not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Group 1 (ACTH-secreting Adenomas)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. rosiglitazone maleate : Given orally–0 / 00 / 0
Group 2 (Non-secreting Macroadenomas)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. rosiglitazone maleate : Given orally–0 / 10 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 such as ketoconazole and/or metyrapone. * Negative pregnancy test * Fertile patients must use effective contraception for at least 2 months prior to, during, and for 1 month after completion of study therapy. * Non-secreting pituitary adenoma * Newly diagnosed disease or residual tumor after prior surgical debulking * Patients underwent prior surgical debulking must be ≥ 3 months post-surgery * More than 10 mm in widest diameter (i.e., macroadenoma), as demonstrated by pituitary MRI performed with and without gadolinium * Must be able to undergo pituitary MRI (group 2) * More than 2 months since prior blood donation \> 400 mL * More than 1 month since prior unlicensed drugs or participation in a clinical trial using an investigational drug * More than 3 months since prior rosiglitazone maleate or other thiazolidinedione * Patients diagnosed with hypopituitarism (except post-menopausal females) are required to initiate hormone-replacement therapy (HRT) for the 6-month duration of the study and to discontinue HRT at the end of 6 months to re-evaluate hypopituitarism Exclusion Criteria: * Acromegaly as demonstrated by normal serum insulin-like growth factor-1 (IGF-1) level * Cushing disease as demonstrated by normal 24-hour UFC cortisol level * Prolactinoma as demonstrated by normal to moderately elevated prolactin levels (moderate elevations in serum prolactin \[\< 200 ng/mL\] can occur in non-secreting tumors due to pituitary stalk displacement) * clinically significant renal, hematologic, cardiac, or hepatic abnormalities within the past month * other active malignancy within the past five years except basal cell carcinoma or carcinoma in situ of the cervix * evidence of drug or alcohol abuse * prior or current medical condition that may interfere with the conduct of the study or evaluation of its results, in the opinion of the Investigator or the Data Safety Monitoring Board compliance officer * postmenopausal female receiving HRT * pregnant or nursing * history of immunocompromise, including known HIV positivity as measured by enzyme-linked immunosorbent assay and western blot * active or suspected acute or chronic uncontrolled infection * history of noncompliance to medical regimens, potentially unreliability, or inability to complete the study * prior or concurrent radiotherapy for pituitary tumor * concurrent pituitary surgery

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