Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma (NCT00079339) | Clinical Trial Compass
CompletedPhase 1/2
Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
United States51 participantsStarted 2004-01
Plain-language summary
Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib to see how well it works when given together with radiation therapy in treating young patients with newly diagnosed brain stem glioma. (Phase I closed to accrual as of 1/19/06)
Who can participate
Age range
3 Years – 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.
Inclusion Criteria:
* Newly diagnosed non-disseminated intrinsic diffuse brainstem glioma
* Karnofsky performance scale (KPS) (for \> 16 yrs of age) or Lansky performance score (LPS) (for =\< 16 years of age) =\> 50 assessed within two weeks prior to registration
* Prior/concurrent therapy:
* Chemo: No prior therapy allowed
* Radiation therapy (XRT): No prior therapy allowed
* Bone Marrow Transplant: None prior
* Anti-convulsants: Patients receiving EIACDs will not be eligible; however, patients may switch from EIACDs to non-EIACDs and must then be on non-EIACDs for a minimum of 7 days prior to registration
* Growth factors: Off all colony forming growth factor(s) \> 2 weeks prior to registration (G-CSF, GM-CSF, erythropoietin)
* Absolute neutrophil count \>= 1,000/mm\^3
* Platelets \>= 100,000/mm\^3 (transfusion independent)
* Hemoglobin \>= 8 gm/dL (transfusion independent)
* Serum creatinine that is less than the upper limit of institutional normal for age or GFR \> 70 ml/min/1.73m2
* Bilirubin =\< 1.5 time upper limit of normal for age
* SGPT (ALT) and SGOT (AST) \< 2.5 times institutional upper limit of normal
* Female patients of childbearing potential must have negative serum or urine pregnancy test; patient must not be pregnant or breast-feeding
* Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
* Signed informed consent ac…
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
Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy
Timeframe: Day 1 of tipifarnib therapy to week 8
2
Progression-free Survival (PFS)
Timeframe: Assessed before the first dose of tipifarnib, every 8 weeks for the first 48 weeks, and then every 12 weeks.