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NCT00612066 · REGISTRY CONDITION SEARCH

Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)

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
2020-08-06

RATIONALE: Rosiglitazone may help pituitary tumor cells become more like normal cells, and to grow and spread more slowly. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).

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

Number of Responders

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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
DISEASE CHARACTERISTICS: * Clinically demonstrable ACTH-secreting pituitary tumor * Pituitary tumor demonstrated on MRI with and without contrast AND/OR evidence of a central ACTH source following inferior petrosal sinus sampling * Newly diagnosed disease * Biochemically active disease that is not adequately controlled, as demonstrated by the following standard criteria: * Elevated 24-hour urinary-free cortisol levels on at least 2 separate 24-hour urine collections 1 week apart * Lack of suppression of serum cortisol to \< 1.8 μg/dL (at 8 am) following administration of 1 mg of dexamethasone at 11 pm the night before * Measurable plasma ACTH levels * Patient is hypercortisolemic and does not wish to receive alternate steroid-lowering therapy, such as ketoconazole and/or metyrapone * Patients with evidence of optic nerve or chiasm compression on post-operative MRI must have a normal visual field evaluation by Goldman perimetry * No visual field abnormalities * Hypopituitarism\* allowed, as evidenced by any or all of the following: * Subnormal growth hormone (GH) response to arginine/growth hormone-releasing hormone (GHRH) testing (normal response is an increase of \> 4 ng/mL) * Low age-and sex-matched insulin-like growth factor-1 (IGF-1) levels * Low thyroid-stimulating hormone (TSH) levels * Low free triiodothyronine (T3) and free thyroxine (T4) levels * Low estradiol levels * Low luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in postmenopausal female patients * Low testosterone, LH, and FSH levels in male patients NOTE: \*Patients who are diagnosed with hypopituitarism will initiate thyroid hormone replacement therapy prior to pituitary surgery as part of routine care. Other hormone replacement, such as sex steroids or growth hormone, will not be initiated during the study. PATIENT CHARACTERISTICS: * Not pregnant or nursing * Fertile patients must use effective contraception (if oral contraception is used, it must be used for ≥ 2 months prior to, during, and for 1 month after completion of study therapy) * No clinically significant renal, hematologic, or hepatic abnormalities * No prior or concurrent medical condition that may interfere with the conduct of the study or the evaluation of its results, in the opinion of the investigator or the DSMB compliance officer * No history of immunocompromise, including HIV positivity by ELISA and western blot * No alcohol or drug abuse within the past 6 months * No blood donation (≥ 400 mL) within the past 2 months * No other active malignant disease within the past 5 years except for basal cell carcinoma or carcinoma in situ of the cervix * No active or suspected acute or chronic uncontrolled infection * No severe osteoporosis, defined as bone mineral density T scores \< 2.5 standard deviations below age-matched controls * No history of noncompliance to medical regimens * Considered reliable * Able to complete the entire study PRIOR CONCURRENT THERAPY: * More than 3 months since prior rosiglitazone or other thiazolidinedione * No prior or concurrent radiotherapy for pituitary tumor * More than 1 month since prior participation in any clinical investigation involving an investigational drug * More than 30 days since prior unlicensed drugs * No 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. intervention Names
    1. Drug: rosiglitazone maleate
    label
    Rosiglitazone
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Rosiglitazone
    name
    rosiglitazone maleate
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Definition of Treatment Response * The primary outcome in Cushing's disease will the % responders, a responder is defined as a patient with 2 consecutive 24h urinary free cortisols within the normal reference range in association with no clinical signs of disease progression. * Secondary outcomes will include the % reduction in 24h UFC (derived by comparison of the mean of 2 baseline 24h UFC values with mean of the two lowest consecutive 24h UFC values while on study treatment in association with no clinical signs of disease progression).
    measure
    Number of Responders
    time Frame
    7 weeks
Full study description
brief Summary
RATIONALE: Rosiglitazone may help pituitary tumor cells become more like normal cells, and to grow and spread more slowly. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).
detailed Description
OBJECTIVES: Primary * To assess the effect of rosiglitazone on biochemical control in patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease). Secondary * To assess the effect of this drug on corticotrophin (CRH)-stimulated pituitary tumor ACTH secretion. * To assess the overall safety and tolerability of this drug in these patients. * To assess the overall quality of life of patients treated with this drug. * Percentage of Reduction in 24-hour Urinary-free Cortisol Levels OUTLINE: This is a multicenter study. Patients receive oral rosiglitazone once daily for 7 weeks in the absence of disease progression or unacceptable toxicity. Blood, urine, and saliva samples are collected periodically for laboratory studies. Inflammatory markers (C-reactive protein, interleukin-6 \[IL-6\], serum sialic acid, soluble intracellular and vascular adhesion molecules \[sICAM-1, and sVCAM-1\], and amyloid A) are measured at baseline and at the completion of study treatment; salivary cortisol and 24-hour urinary-free cortisol levels are measured at baseline and weekly during study treatment; dexamethasone suppression tests with serum cortisol and corticotrophin (CRH) stimulation test are performed at baseline and at the completion of study treatment; prolactin, insulin-like growth factor-1 (IGF1), thyroid function, and sex steroid hormones are measured at baseline and at the completion of study treatment; and dynamic pituitary function testing (arginine/growth hormone-releasing hormone \[GHRH\] testing to measure growth hormone secretion) is performed at baseline.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-0bc13514225d518a32b7
      requested nct id
      NCT00612066
      primary nct id
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      source kind
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      source file sha256
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      payload sha256
      a9f36b457b2b2a545df3e606012245c8a39bd4c3e9fa60429a4b3dd084d3f3a1
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-0bc13514225d518a32b7
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT00612066
        end
        11
        exact text
        NCT00612066
        start
        0
      offset unit
      unicode_code_points
      query cond
      Pituitary Tumors
      query disease state id
      ds-pituitary-tumors
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-pituitary-tumors-000.json
      source file sha256
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      source json pointer
      /studies/24/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      3adbb64c518cfc5f96d9e54a8a7919891ea9beddc933ce7c7e5ddeadcf7d046a

    Preserved source evidence · Not medical advice