Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00099060
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Brain and Central Nervous System Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lapatinib ditosylate — DRUG
    For patients receiving enzyme inducing anti-epileptic drugs (EIAEDs): * Phase I: starting dose for first cohort: 1000 mg GW572016 po b.i.d.; actual dose assigned at registration; intra patient dose escalation permitted ONCE in phase I patients ONLY if specified criteria met (see section 8.6). * Phase II: Recommended phase II dose from phase I portion of the study, given po b.i.d. For patients NOT receiving enzyme inducing anti-epileptic drugs (NON-EIAEDs): • Phase II: 750 mg GW572016 po b.i.d. For all patients: • Dose reductions as required based on adverse events.

Study Details

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and to see how well it works in treating patients with recurrent glioblastoma multiforme.

Key Dates

Start date
Dec 31, 2004
Status verified
Apr 2012
Primary completion
Nov 30, 2007
Completion
Nov 30, 2007

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Toxicity for phase I assessed by CTCAE v.3.0 MacDonald criteria [ Time Frame: 7 years ]

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