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Brain and Central Nervous System TumorsPhase 2NCT00616642

Rosiglitazone in Treating Patients With Pituitary Tumors

A Phase 2 study testing rosiglitazone maleate in people with Brain and Central Nervous System Tumors, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
rosiglitazone maleate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Oct 2006to Nov 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: Rosiglitazone (Peroxisome Proliferating Activating Receptor-gamma {PPAR-y} Ligand) Treatment of Pituitary Tumors

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.

Read the detailed description

OBJECTIVES:

  • To assess the effect of rosiglitazone maleate on the core biochemical parameter, 24-hour urinary free cortisol levels, in patients with recurrent or uncured pituitary-dependent Cushing disease. (Group 1)
  • To assess the effect of this drug on corticotropin-releasing hormone-stimulated pituitary tumor ACTH secretion in patients with recurrent or uncured pituitary-dependent Cushing disease. (Group 1)
  • To assess the effect of this drug on tumor growth in patients with non-secreting pituitary macroadenoma (> 10 mm) using RECIST criteria. (Group 2)
  • To assess the effect of this drug on pituitary tumor gonadotropin (i.e., follicle-stimulating hormone, leuteinizing hormone, and alpha-subunit) secretion in patients with non-secreting macroadenoma. (Group 2)
  • To assess the overall safety and tolerability of this drug in both cohorts of patients.
  • To assess the overall quality of life, in terms of performance status during treatment, of both cohorts of patients using the Karnofsky performance index.

OUTLINE: Patients are grouped according to adrenocorticotropic hormone (ACTH)-secreting status (yes [Group 1] vs no [Group 2]).

  • 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.
  • 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.

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.

Being tested
rosiglitazone maleate
Keywords
recurrent pituitary tumor, ACTH-producing pituitary tumor, nonfunctioning pituitary tumor
Medical subject headings
Central Nervous System Neoplasms, Pituitary Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rosiglitazone maleateDrug

    Given orally

Study groups in NCT00616642
Study groupRoleWhat they receive
Group 1 (ACTH-secreting adenomas)ExperimentalPatients 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.
Receives: Drug: rosiglitazone maleate
Group 2 (non-secreting macroadenomas)ExperimentalPatients 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.
Receives: Drug: rosiglitazone maleate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Rosiglitazone Maleate on Cushing Disease

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2008 (estimated)
  2. Study startOct 2006
  3. Primary completionNov 2010
  4. Study completionNov 2010

Why it stopped: low patient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00616642
Sponsor's protocol ID
CDR0000586480
Other IDs
UCLA-0411082-03
Status last verified
Mar 2013
First submitted
14 Feb 2008
Last updated
14 Aug 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rosiglitazone maleate in people with Brain and Central Nervous System Tumors, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Rosiglitazone Maleate on Cushing Disease (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00616642.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.

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