Cushing's DiseasePhase 2NCT00612066
Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)
A Phase 2 study testing rosiglitazone maleate in people with Cushing's Disease, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cushing's Disease
- What is being tested?
- rosiglitazone maleate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to 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
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's Disease
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).
Read the 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.
- Conditions
- Cushing's Disease
- Being tested
- rosiglitazone maleate
- Keywords
- ACTH-producing pituitary tumor
- Medical subject headings
- Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazone maleateDrug
| Study group | Role | What they receive |
|---|---|---|
| Rosiglitazone | Experimental | Not described Receives: Drug: rosiglitazone maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responders
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).
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startApr 2007
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Low accrual and funding term ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Anthony Heaney, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612066
- Sponsor's protocol ID
- CDR0000586468
- Other IDs
- UCLA-0612080-01
- Status last verified
- Jan 2016
- First submitted
- 8 Feb 2008
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's Disease
- ClinicalTrials.gov ID
- NCT00612066
- Acronym / sponsor ID
- CDR0000586468
- Conditions
- Cushing's Disease
- Keywords
- ACTH-producing pituitary tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual and funding term ended
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Posted 17 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosiglitazone | Experimental | Drug: rosiglitazone maleate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosiglitazone maleate | Drug | Rosiglitazone |
Primary outcome
Number of Responders
Time frame: 7 weeks
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cushing's Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Heaney, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rosiglitazone maleate in people with Cushing's Disease, 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?
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 6 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 17 Feb 2016). 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?
Number of Responders (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2020.