Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors (NCT00020150) | Clinical Trial Compass
CompletedPhase 1
Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors
United StatesStarted 2000-06
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating children who have solid tumors that have not responded to previous therapy.
Who can participate
Age range
21 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 solid tumor refractory to standard therapy and for which no potentially curative therapy exists, including, but not limited to:
* Rhabdomyosarcoma and other soft tissue sarcomas
* Ewing's family of tumors
* Osteosarcoma
* Neuroblastoma
* Wilms' tumor
* Hepatic tumors
* Germ cell tumors
* Primary brain tumor
* Histological confirmation may be waived for brainstem or optic gliomas
* Measurable or evaluable disease
* Evidence of progressive disease on prior chemotherapy or radiotherapy or persistent disease after prior surgery
PATIENT CHARACTERISTICS:
Age:
* 21 and under
Performance status:
* ECOG 0-2
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute granulocyte count greater than 1,500/mm\^3
* Hemoglobin greater than 8 g/dL
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin normal
* SGPT less than 2 times upper limit of normal
* No significant hepatic dysfunction
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No significant cardiac dysfunction
Pulmonary:
* No significant pulmonary dysfunction
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to swallow capsules
* No significant unrelated systemic illness that would preclude study (e.g., serious infections or organ dysfunction)
* No prior hypersensitivity to dacarbazine, temozolomide, or polyethylene glycol…
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.