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Brain and Central Nervous System TumorsPhase 2NCT00601289

Temozolomide in Treating Patients With Invasive Pituitary Tumors

A Phase 2 study testing temozolomide, DNA methylation analysis and microarray analysis in people with Brain and Central Nervous System Tumors, run by Jonsson Comprehensive Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with invasive pituitary tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
temozolomide, DNA methylation analysis and microarray analysis
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2009to Oct 2010
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Clinically demonstrable invasive pituitary macroadenoma, including any of the following subtypes:
  • Growth hormone-secreting
  • Prolactin-secreting
  • Adrenocorticotrophic hormone-secreting
  • Non-secreting
  • Must have biochemical evidence of any of the following:
  • Acromegaly as measured by serum insulin-like growth factor-1 (IGF-1)
  • Prolactinoma as measured by serum prolactin (PRL)
  • Cushing's disease as measured by 24-hour urinary-free cortisol
  • Inadequate tumor control, defined as a visible pituitary tumor ≥ 1 cm in maximal diameter encasing the carotid arteries, and/or invading into the cavernous sinuses, and/or abutting/invading the optic chiasma as demonstrated by MRI scan with or without contrast
  • Previously assessed by radiosurgery and meets ≥ 1 of the following criteria:
  • Not a suitable candidate for radiotherapy (e.g., tumor abutting and/or invading the optic chiasm)
  • Declined radiotherapy (in light of side effects or personal choice)
  • Has not exhibited tumor shrinkage or tumor continues to grow ≥ 1 year after completion of radiotherapy
  • 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 response to arginine/growth hormone-releasing hormone testing (normal response is an increase of > 4 ng/mL)
  • Low age- and sex-matched IGF-1 levels
  • Low thyroid-stimulating hormone (TSH), 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 OR low testosterone, LH, and FSH levels in male patients
  • Serum cortisol < 3 ng/mL (at 8 am)
  • Patients diagnosed with hypopituitarism (except for post-menopausal females) are required to initiate hormone replacement therapy for the 12-month duration of the study and to discontinue hormone replacement therapy at the end of 12 months to re-evaluate hypopituitarism

PATIENT CHARACTERISTICS:

  • Able to undergo a pituitary MRI scan
  • 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 Data Safety Monitoring Board compliance officer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for ≥ 2 months prior to, during, and for 1 month after completion of study therapy
  • No history of immunocompromise, including known HIV positivity as measured by enzyme linked immunosorbent assay (ELISA) and western blot
  • No alcohol or drug abuse within the past 6 months
  • No blood donation within the past 2 months
  • No history of noncompliance to medical regimens, potential unreliability, or inability to complete the entire study
  • No other active malignant disease within the past 5 years, except basal cell carcinoma or carcinoma in situ of the cervix
  • No active or suspected acute or chronic uncontrolled infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior pituitary surgery allowed provided the surgery failed to induce complete tumor response and the patient is deemed unsuitable for further pituitary surgeries
  • At least 3 months since prior pituitary surgery
  • More than 1 month since prior unlicensed drugs or participation in a clinical trial with an investigational drug
  • No concurrent pituitary surgery or pituitary radiotherapy
  • No other concurrent therapy to reduce pituitary tumor size

About this study

Official title: An Open Label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Temozolomide Treatment in Patients With Invasive Pituitary Tumors

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with invasive pituitary tumors.

Read the detailed description

OBJECTIVES:

Primary

  • To assess the effect of temozolomide on pituitary tumor growth in patients with invasive pituitary tumors.
  • To assess the effect of temozolomide on pituitary tumor response and the duration of tumor response in these patients.

Secondary

  • To assess the effect of temozolomide on pituitary tumor hormone secretion in these patients.
  • To assess the effect of temozolomide on other aspects of pituitary function in these patients.
  • To assess the overall safety and tolerability of temozolomide in these patients.
  • To assess the overall quality of life of patients treated with temozolomide.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of 12 courses, patients achieving a complete or partial tumor response may continue to receive temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected periodically to assess methylation status of the methyl-guanine methyl-transferase promoter (MGMT) gene and to quantitate immunocytochemical expression of the tumor suppressor proteins p53, p16, and p27. Tissue samples are also analyzed by microarray and proteomics to determine a genetic "signature" of invasive vs non-invasive pituitary tumors and to determine if this signature correlates with response to temozolomide. Blood samples are also periodically for biomarker laboratory studies.

Patients complete a quality of life questionnaire periodically.

After completion of study therapy, patients are followed for 28 days.

Being tested
temozolomide, DNA methylation analysis, microarray analysis, protein expression analysis, proteomic profiling
Keywords
pituitary chromophobe adenoma, recurrent pituitary tumor, ACTH-producing pituitary tumor, growth hormone-producing pituitary tumor, prolactin-producing pituitary tumor, pituitary basophilic adenoma, pituitary eosinophilic adenoma, prolactin secreting adenoma, nonfunctioning pituitary tumor
Medical subject headings
Central Nervous System Neoplasms, Adenoma, Chromophobe, Pituitary Neoplasms, Growth Hormone-Secreting Pituitary Adenoma, Adenoma, Basophil, Adenoma, Acidophil, Prolactinoma

What participants receive

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

  • temozolomideDrug

  • DNA methylation analysisGenetic

  • microarray analysisGenetic

  • protein expression analysisGenetic

  • proteomic profilingGenetic

  • laboratory biomarker analysisOther

What is being measured

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

  1. Change from baseline of pituitary tumor control as assessed by MRI at 3, 6, 9, and 12 months

    Measured: 1 year

  2. Change in Tumor response rate (complete response or partial response) from baseline as assessed by RECIST criteria at 3, 6, 9, and 12 months

    Measured: 1 year

  3. Rebound tumor growth as assessed by MRI at 6 months after completion of treatment

    Measured: 6 months

Secondary outcomes (4)

  1. Biochemical control as assessed by measurement of hormones secreted in excess by the pituitary tumor at baseline, at 3, 6, 9, and 12 months during treatment, and then at 2 months after completion of treatment

    Measured: 14 months

  2. Pituitary function as assessed by standard pituitary function tests at baseline and at 6 months and 12 months

    Measured: 1 year

  3. Safety and tolerability of temozolomide as assessed by NCI CTC v2.0 at screening, baseline, and then monthly until study completion

    Measured: 1 year

  4. Overall quality of life as assessed by Karnofsky performance status questionnaire periodically during study

    Measured: 1 year

Timeline

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

  1. First posted28 Jan 2008 (estimated)
  2. Study startDec 2009
  3. Primary completionOct 2010

Why it stopped: funding term ended

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00601289
Sponsor's protocol ID
CDR0000577534
Other IDs
07-05-077-01
Status last verified
Jul 2012
First submitted
25 Jan 2008
Last updated
31 Jul 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temozolomide, DNA methylation analysis and microarray analysis in people with Brain and Central Nervous System Tumors, run by Jonsson Comprehensive Cancer Center.

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: withdrawn, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Change from baseline of pituitary tumor control as assessed by MRI at 3, 6, 9, and 12 months (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT00601289.

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 31 Jul 2020.

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