Tipifarnib in Treating Young Patients With Recurrent or Progressive High-Grade Glioma, Medulloblastoma, Primitive Neuroectodermal Tumor, or Brain Stem Glioma
Completed · Phase 2
Conditions studied: Childhood High-grade Cerebral Astrocytoma, Childhood Oligodendroglioma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma
In brief
This phase II trial is studying how well tipifarnib works in treating young patients with recurrent or progressive high-grade glioma, medulloblastoma, primitive neuroectodermal tumor, or brain stem glioma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Key facts
- Study ID
- NCT00070525
- Run by
- National Cancer Institute (NCI)
- People needed
- 90
- Starts
- 2003-11-01
- Last updated by the study team
- 2013-10-08
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed brain tumor, including the following:
- Anaplastic astrocytoma
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic oligodendroglioma
- Medulloblastoma/primitive neuroectodermal tumor (PNET)
- Diffuse intrinsic brain stem glioma*
- Progressive or relapsed disease after prior conventional therapy
- Radiographic evidence of measurable disease
- Performance status - Karnofsky 60-100% (over 16 years of age)
- Performance status - Lansky 60-100% (16 years of age and under)
- Performance status - ECOG 0-2
- At least 8 weeks
- Absolute neutrophil count at least 1,000/mm\^3
- Platelet count at least 100,000/mm\^3 (transfusion independent)
- Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed)
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGPT and SGOT less than 2.5 times ULN
- Creatinine clearance OR radioisotope glomerular filtration rate at least 70 mL/min
- Maximum creatinine based on age as follows:
- 0.8 mg/dL (5 years and under)
- 1.0 mg/dL (6 to 10 years)
- 1.2 mg/dL (11 to 15 years)
- 1.5 mg/dL (over 15 years)
- Shortening fraction at least 27% by echocardiogram
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.