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Tyrosine Kinase Inhibitor

Lapatinib Before Surgery for Brain Tumor

Phase 1

Waitlist Available

Led By Timothy F Cloughesy

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically proven World Health Organization (WHO) grade IV glioblastoma/gliosarcoma or WHO grade III glioma which is progressive or recurrent following radiation therapy +/- chemotherapy

Patients must have a Karnofsky performance status >= 60%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing how well lapatinib ditosylate works in treating patients with high-grade glioma that has come back. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for adults with high-grade glioma brain tumors that have returned after treatment. Eligible patients must have had prior therapy, be able to undergo MRI and surgery, and have a certain level of physical function. They should not be on specific drugs or have other serious health issues, and women must agree to use contraception.Check my eligibility

What is being tested?

The study tests how well lapatinib ditosylate works when given before surgery in patients with recurrent high-grade gliomas. The drug aims to block enzymes needed for tumor cell growth, potentially slowing the disease's progression.See study design

What are the potential side effects?

Potential side effects of lapatinib ditosylate may include diarrhea, skin rashes, fatigue, nausea, liver problems like hepatitis or abnormal liver function tests; heart issues such as decreased heart function; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain tumor is aggressive and has returned or worsened after treatment.

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I can care for myself but may need occasional help.

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I have no other cancers except possibly treated skin, cervical, breast, or bladder cancer.

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I can take medication by mouth, including tablets.

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My brain tumor is growing or has returned, and it can be seen on an MRI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To Determine the Lapatinib Ditosylate Intratumoral Concentration (Pharmacokinetics)

To Determine the Ratio of Phosphorylated (p)EGFR/Total EGFR (PD) in Tumor Tissue

Secondary outcome measures

Ex-vivo Sensitivity of Tumor Sphere Cultures to Lapatinib Ditosylate

Incidence of Adverse Events (AEs)

Inhibition of tumor cell proliferation (KI-67)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A (lapatinib ditosylate, surgery)Experimental Treatment5 Interventions

Patients receive lapatinib ditosylate PO BID on days -2 to 0. Within 3-5 hours after last dose of lapatinib ditosylate, patients undergo surgical resection of tumor on day 0. Within 30 days of surgical resection of tumor, patients receive lapatinib ditosylate BID for 2 days every 7 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Reference Group (surgery, lapatinib ditosylate)Active Control5 Interventions

Patients undergo surgery on day 0. Within 30 days of surgical resection of tumor, patients receive lapatinib ditosylate BID for 2 days every 7 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lapatinib Ditosylate

2006

Completed Phase 3

~580

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850