Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00099060
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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.

Detailed Description

OBJECTIVES:

Phase I

* Determine the maximum tolerated dose and recommended phase II dose of lapatinib in patients with recurrent malignant glioblastoma multiforme who are taking CYP3A4 enzyme-inducing anti-epileptic drugs (EIAEDs).

* Determine the toxic effects of this drug in these patients.

* Determine the pharmacokinetics of this drug in these patients.

Phase II

* Determine the efficacy of this drug, in terms of objective tumor response rate, in patients who are taking EIAEDs and in those who are not taking EIAEDs.

* Correlate immunohistochemical measures of cellular proteins and receptors from tumor samples with anti-tumor activity of this drug in these patients.

* Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter, open-label, phase I, dose-escalation study followed by a phase II study.

* Phase I: Patients receive oral lapatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of lapatinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

* Phase II: Patients receive lapatinib as in phase I at the MTD. Patients are followed at 1 month and then periodically for survival. Patients with stable or responding disease who go off therapy are followed every 3 months for up to one year and then periodically thereafter for survival.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 18 months. A total of 15-30 patients will be accrued for the phase II portion of this study within 18 months.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2004-12-08
• Study First Submitted QC: 2004-12-08
• Study First Posted: 2004-12-09
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2012-04
• Last Update Submitted: 2014-01-24
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Toxicity for phase I assessed by CTCAE v.3.0 MacDonald criteria	7 years
Response for phase II	7 years

Secondary Outcome Measures

Name	Time	Method
Correlative studies on archival tissue	7 years
Pharmacokinetics	7 years

Trial Locations

Locations (6)

British Columbia Cancer Agency - Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

British Columbia Cancer Agency - Vancouver Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

Tom Baker Cancer Centre - Calgary; 🇨🇦 Calgary, Alberta, Canada

Margaret and Charles Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada