CompletedPhase 1

O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors

United States, Australia, Canada36 participantsStarted 1999-05

Plain-language summary

Phase I trial to study the effectiveness of O6-benzylguanine and carmustine in treating children who have refractory CNS tumors. 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.

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 or cytologically proven CNS tumor that is refractory to conventional therapy or for which no effective therapy is known * Histological requirement may be waived for brainstem and optic gliomas * Stratum 2: No bone marrow involvement PATIENT CHARACTERISTICS: * Age: 21 and under * Performance status: Karnofsky 50-100% OR Lansky 50-100% * Life expectancy: At least 8 weeks * Absolute neutrophil count at least 1500/mm3 * Platelet count at least 100,000/mm3 (stratum 2: at least 125,000/mm3) * Hemoglobin at least 8 g/dL * Bilirubin less than 1.5 mg/dL * SGOT/SGPT no greater than 2.5 times normal * Creatinine or GFR normal for age * If required, DLCO must be 80% of normal and patient old enough to cooperate for DLCO test * Neurologic deficits must be stable for at least 2 weeks prior to study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: * At least 7 days since prior biologic therapy or immunotherapy and recovered * At least 6 months since prior bone marrow transplant (stratum 1 only) * At least 7 days since prior growth factors * No concurrent filgrastim (G-CSF) prophylaxis * Stratum 2: No prior bone marrow transplantation * At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered * Stratum 2: No greater than 2 prior chemotherapy regimens * No prior nitrosourea therapy * If rec…

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.

Trial details

NCT IDNCT00003765

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2006-03

View on ClinicalTrials.gov More Brain and Central Nervous System Tumors trials

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.