Skip to content

Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT00612066 (opens ClinicalTrials.gov in a new tab)Other idCDR0000586468Other idUCLA-0612080-01

This trial does not test a peptide that PepBank tracks.

  • Measures ACTH (corticotropin), does not give it. It appears in the eligibility rules.

Overview

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

United States

Start
Apr 2007
Primary completion
Nov 2010
Completion
Nov 2010
First posted
11 Feb 2008 (estimated)
Last update posted
6 Aug 2020
Conditions
Cushing's Disease

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008200920102011
  1. Ph 2

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

    NCT00612066

    Apr 2007 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 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).

Interventions

  • rosiglitazone maleateDrug

Arms1

  • Experimental

    Rosiglitazone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Responders

    Time frame · 7 weeks

    Registry 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).

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 outcomeNumber· 7 weeks

Number of Responders

GroupValue (participants)
Rosiglitazone1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
RosiglitazoneRosiglitazone maleate :–0 / 21 / 2

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
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

PepBank is a research reference. Talk to a doctor before you use any peptide.