CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
lapatinib ditosylate +5 moredrug
Likely dose
Lapatinib ditosylate given orally (specific dose not specified in criteria or arms)AI-extracted
Key inclusion· 13
  • ✓Recurrent or refractory medulloblastoma/PNET, high-grade glioma (anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, anaplastic oligodendroglioma), or ependymoma with histological diagnosis
  • ✓Measurable disease on imaging
  • ✓KPS ≥50 (age >16 years) or LPS ≥50 (age ≤16 years)
  • ✓Neurological deficits stable for minimum 1 week prior to registration
Key exclusion· 8
  • ✕Any significant medical illnesses that cannot be adequately controlled or would compromise ability to tolerate therapy
  • ✕Any disease that would obscure toxicity or dangerously alter drug metabolism
  • ✕Uncontrolled infection
  • ✕CYP3A4 inhibitors within 7 days prior to registration (amiodarone must be discontinued 6 months prior)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00095940
NCT00095940Phase 2Completed
CompareCT.gov

Molecular Biology and Phase II Study of Lapatinib (GW572016) in Pediatric Patients With Recurrent or Refractory Medulloblastoma, Malignant Glioma or Ependymoma

National Cancer Institute (NCI)·interventional·Posted Nov 9, 2004·Updated May 23, 2014

In Brief

A Phase 2 clinical trial evaluating lapatinib ditosylate, therapeutic conventional surgery, and 4 other interventions for Recurrent Childhood Anaplastic Astrocytoma and 7 related conditions. Completed, enrolled 52 participants across 1 site.

Detailed Summary

This phase I/II trial studies lapatinib to see how well it works in treating young patients with recurrent or refractory central nervous system (CNS) tumors. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Childhood Anaplastic Astrocytoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Ependymoma, Recurrent Childhood Giant Cell Glioblastoma, Recurrent Childhood Glioblastoma, Recurrent Childhood Gliosarcoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Oligodendroglioma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2004
Enrollment StartOct 1, 2004
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 21.6 years ago

Interventions

lapatinib ditosylatedrug

Given orally

therapeutic conventional surgeryprocedure

Undergo surgery

laboratory biomarker analysisother

Correlative studies

pharmacological studyother

Correlative studies

positron emission tomographyprocedure

Correlative studies

magnetic resonance imagingprocedure

Correlative studies