Temozolomide in Treating Patients With Invasive Pituitary Tumors (NCT00601289) | Clinical Trial Compass
WithdrawnPhase 2
Temozolomide in Treating Patients With Invasive Pituitary Tumors
Stopped: funding term ended
0Started 2009-12
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline of pituitary tumor control as assessed by MRI at 3, 6, 9, and 12 months
Timeframe: 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
Timeframe: 1 year
3
Rebound tumor growth as assessed by MRI at 6 months after completion of treatment