Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors

Conditions

• Recurrent 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

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• lapatinib ditosylate — DRUG
  Given orally
• therapeutic conventional surgery — PROCEDURE
  Undergo surgery
• laboratory biomarker analysis — OTHER
  Correlative studies
• pharmacological study — OTHER
  Correlative studies
• positron emission tomography — PROCEDURE
  Correlative studies
• magnetic resonance imaging — PROCEDURE
  Correlative studies

Study Details

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.

Key Dates

Start date

Oct 31, 2004

Status verified

Jan 2013

Primary completion

Jul 31, 2010

Completion

Jul 31, 2010

Study Design

Enrollment

52 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (surgery, lapatinib)
  Molecular Biology Phase: Patients randomized to receive lapatinib prior to surgery receive oral lapatinib twice daily for 7-14 days. Surgery is performed after 7-14 days of lapatinib treatment. For patients randomized to not receive lapatinib, surgery is performed within 3 weeks of registration. After surgical resection, all molecular biology participants start lapatinib treatment within 10 days post-surgery. The first dose of lapatinib post-surgery initiates course 1. Patients receive oral lapatinib twice daily on days 1-28. Treatment repeats every 28 days for up to 26 courses (2 years) in the absence of disease progression or unacceptable toxicity. Lapatinib Continuation/Phase II: Patients receive oral lapatinib twice daily on days 1-28. Treatment repeats every 28 days for up to 26 courses (2 years) in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Relative Phosphorylation of ERBB2 (Molecular Biology Objective) [ Time Frame: 7-14 days after starting therapy and prior to surgery ]

Locations (1)

Find similar trials in Memphis, TN

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  PHASE1 · Recruiting · Florida International University · Miami, Florida