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NCT00616642 · REGISTRY CONDITION SEARCH

Rosiglitazone in Treating Patients With Pituitary Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2020-08-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Efficacy of Rosiglitazone Maleate on Cushing Disease

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
65 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: rosiglitazone maleate
    label
    Group 1 (ACTH-secreting adenomas)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: rosiglitazone maleate
    label
    Group 2 (non-secreting macroadenomas)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Group 1 (ACTH-secreting adenomas)
    2. Group 2 (non-secreting macroadenomas)
    description
    Given orally
    name
    rosiglitazone maleate
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.
    measure
    Efficacy of Rosiglitazone Maleate on Cushing Disease
    time Frame
    12 months
Full study description
brief 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.
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.
Source references
Source notices and limitations
    Discovery and provenance
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      nct id
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      occurrences
      1. context exact
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        end
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        exact text
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        start
        0
      offset unit
      unicode_code_points
      query cond
      Pituitary Tumors
      query disease state id
      ds-pituitary-tumors
      source file
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      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice