Temozolomide in Treating Patients With Progressive Low-Grade Glioma (NCT00003466) | Clinical Trial Compass
CompletedPhase 2
Temozolomide in Treating Patients With Progressive Low-Grade Glioma
United States100 participantsStarted 1998-03
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.
Who can participate
Age range
4 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:
* Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:
* Astrocytoma
* Oligodendroglioma
* Mixed glioma
* Optic pathway glioma\*
* Pontine glioma\* NOTE: \*Biopsy not required
* Patients with optic pathway glioma must also meet the following criteria:
* Progressive loss of vision as defined by doubling of octaves
* Visual acuity loss not explained by other causes
* Increase in proptosis of greater than 3 mm
* Increase in diameter of optic nerve of at least 2 mm on neuroimaging
* Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
* 4 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* More than 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT less than 2.5 times ULN
* Alkaline phosphatase less than 2 times ULN
Renal:
* Creatinine less than 1.5 times ULN
* BUN less than 1.5 times ULN
Other:
* Must be neurologically stable
* No systemic disease
* No acute infection requiring IV antibiotics
* No frequent vomiting
* No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction)
* No other prior or concurrent malignancies except:
* Surgically cured c…
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.