Safety Study of High Dose Temozolomide to Treat Relapsed/Refractory Central Nervous System (CNS) … (NCT00629187) | Clinical Trial Compass
TerminatedPhase 1
Safety Study of High Dose Temozolomide to Treat Relapsed/Refractory Central Nervous System (CNS) Malignancy
Stopped: The study was stopped due to lack of adequate enrollment.
United States2 participantsStarted 2004-04
Plain-language summary
The goal of this study is to find the maximum dose of a drug, temozolomide, that can safely be given to subjects with brain tumors. Past studies showed that the maximum dose of temozolomide was limited by low blood counts. The investigators will use blood stem cells collected from bone marrow to help subjects recover their blood counts, a procedure called autologous stem cell transplant or stem cell rescue. This way, the investigators expect to be able to safely deliver very high doses of temozolomide. This study is only available at Tufts Medical Center.
Who can participate
Age range
18 Years – 70 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.
Inclusion Criteria:
* Patients or their health care proxies must be able to provide consent to participate in this trial.
* Patients must have one of the following diagnoses which has not responded or recurred following at least one prior chemotherapy regimen or radiation therapy:
* anaplastic astrocytoma, glioblastoma multiforme or oligodendroglioma
* primary CNS lymphoma
* malignant disease metastatic to the CNS
* Patients must be candidates for high dose chemotherapy and autologous stem cell transplant according to the following criteria:
* Patients must be between the ages of 18 and 70 years (inclusive)
* Patients must have a left ventricular ejection fraction greater than or equal to 45% by MUGA or echocardiogram
* Patients must have adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of predicted
* Patients must have serum direct bilirubin less than or equal to 2.0 mg/dl and transaminases less than or equal to 3x institutional upper limit of normal
* Patients must have serum creatinine less than or equal to 2 mg/dl with creatinine clearance greater than or equal to 60 ml/min (either calculated or measured)
* Patients must have an ECOG performance status between 0 and 2
* Patients must be at least 4 weeks from last cytoreductive chemotherapy.
* Expected survival of at least 3 months
Exclusion Criteria:
* Patients with uncontrolled metastatic disease outside of the CNS which would itself, in the investigator's opinion, l…
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
Determine the maximum tolerated dose of temozolomide with hematopoietic stem cell rescue in patients with recurrent CNS malignancy