Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas (NCT00610571) | Clinical Trial Compass
CompletedPhase 1
Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
United States62 participantsStarted 2004-04
Plain-language summary
Objectives:
* To determine the maximum tolerated dose of oral topotecan when administered with Temodar to patients with malignant glioma
* To characterize any toxicity associated with the combination oral topotecan and Temodar.
* To observe patients for clinical antitumor response when treated with oral topotecan and Temodar.
Who can participate
Age range
18 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:
* Histology: GBM, AA or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors which were initially diagnosed by histologic exam of biopsy/resection
* Age: \> or equal to 18 years
* Performance Status: Karnofsky Performance Status \> or equal to 60% at study entry.
* Renal Function: Serum creatinine \< 1.5 mg/dl or creatinine clearance \> 60 ml/dL.
* Hematologic Status: The following baseline studies will be required before entry: total granulocyte count \> or equal to 1000/microliter; platelet count \> 100,000/microliter
* Hepatic Function: Serum SGOT \& total bilirubin \< or equal to 2.5 times ULN.
* Note: All lab parameters must have been obtained within 1 week of registration
* Consent: Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
* Corticosteroids: For patients currently on corticosteroids, patients should be on stable dose for 1 week prior to study entry, if clinically possible.
* Prior Therapy: Interval of at least 2 weeks between prior surgical resection or prior radiotherapy (XRT) or 1 week from completion of chemotherapy and all toxicities are \< or equal to grade 1 \& enrollment on this protocol unless there is unequivocal evidence of progressive disease.
* Patients with Reproductive Potential: Patients must agree to practice effective birth control measures while on study and for 2 months after completing therapy
Exclusion Criteria:
* Pregnant or breast feeding women or women or …
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.