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Tyrosine Kinase Inhibitor

Lapatinib + Temozolomide + Radiation for Glioblastoma

Phase 2

Waitlist Available

Led By Pioanh Nghiemphu, M D

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with histologically proven intracranial Glioblastoma Multiforme (GBM) or gliosarcoma (GS), including treatment-naïve patients with prior tissue diagnoses of lower grade gliomas upgraded to GBM after repeat resection

Age > 18 years with life expectancy > 12 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is for patients with newly diagnosed glioblastoma multiforme. The standard treatment for this cancer is radiation therapy and the chemotherapy agent Temozolomide. However, the study drug Lapatinib has not been FDA approved for use in brain tumor treatment. This study is testing to see if Lapatinib is safe and effective when given in combination with radiation therapy and Temozolomide.

Who is the study for?

This trial is for adults over 18 with newly-diagnosed Glioblastoma Multiforme or gliosarcoma who haven't started treatment. They must start therapy within 2-5 weeks post-surgery, have tissue samples available, use contraception, and have an MRI or CT scan done recently. Good performance status and adequate organ function are required.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Lapatinib (not yet FDA-approved for brain tumors) combined with standard radiation therapy and Temozolomide chemotherapy in patients with brain cancer. It aims to determine if this combination can shrink tumors safely.See study design

What are the potential side effects?

Potential side effects include those common to chemotherapy like nausea, fatigue, blood cell count changes leading to increased infection risk; plus any unique reactions from Lapatinib which could involve skin rashes or diarrhea.

Eligibility Criteria

Inclusion Criteria

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

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I have a confirmed diagnosis of GBM or GS, possibly upgraded from a lower grade after surgery.

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I am over 18 years old and expected to live more than 12 weeks.

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I can care for myself but may not be able to do active work.

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I agree not to take other cancer drugs during my lapatinib, temozolomide, and radiation treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lapatinib/Temozolomide/radiationExperimental Treatment1 Intervention

Patients will be treated with a pulse dose of lapatinib every week and temozolomide 75 mg/m2 daily during radiation. Lapatinib will be administered beginning on the first day of radiation and temozolomide (+/-2 days). External beam fractionated regional radiation will be given on consecutive week days at 200 cGy daily doses to a total dose of 6000 cGy. Patients will have rest from temozolomide only for 2-4 weeks. Patients will continue with weekly pulse-dosing of lapatinib. After a 2-4 weeks rest(for temozolomide only) following completion of radiation therapy, temozolomide will be restarted as Cycle 1 at 150 mg/m2/day for 5 days out of every 28.Subsequent cycles can increase to 200 mg/m2/day as tolerated per investigator's judgment. Lapatinib pulse doses will be continued every week without interruption.Treatment will continue for 24 additional 28-day cycles of temozolomide if there is no evidence of progression.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

NovartisIndustry Sponsor

1,610 Previous Clinical Trials

2,719,220 Total Patients Enrolled

12 Trials studying Glioblastoma

711 Patients Enrolled for Glioblastoma

GlaxoSmithKlineIndustry Sponsor

4,750 Previous Clinical Trials

8,067,402 Total Patients Enrolled

7 Trials studying Glioblastoma

336 Patients Enrolled for Glioblastoma

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,025 Total Patients Enrolled

17 Trials studying Glioblastoma

476 Patients Enrolled for Glioblastoma

Media Library

Lapatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01591577 — Phase 2

Glioblastoma Research Study Groups: Lapatinib/Temozolomide/radiation

Glioblastoma Clinical Trial 2023: Lapatinib Highlights & Side Effects. Trial Name: NCT01591577 — Phase 2

Lapatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01591577 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent are Lapatinib, Temozolomide and radiation therapy safe for individuals receiving treatment?

"Lapatinib/Temozolomide/radiation has been given a safety score of 2, as there are some clinical data to support its security but no evidence yet verifying its effectiveness."

Answered by AI

Are there any available slots left for individuals to participate in this research?

"According to clinicaltrials.gov, this research project is not presently accepting participants; the initial listing was posted on December 7th 2012 and last updated September 9th 2022. Nonetheless, there are currently 441 other trials seeking volunteers."

Answered by AI

Recent research and studies

Journal of Neuro-OncologyJournal

Report of Safety of Pulse Dosing of Lapatinib with Temozolomide and Radiation Therapy for Newly-diagnosed Glioblastoma in a Pilot Phase II Study

Yu, Andrew, Nadia Faiq, Stacey Green, Albert Lai, Richard Green, Jethro Hu, Timothy F. Cloughesy, Ingo Mellinghoff, and P. Leia Nghiemphu. 2017. “Report of Safety of Pulse Dosing of Lapatinib with Temozolomide and Radiation Therapy for Newly-diagnosed Glioblastoma in a Pilot Phase II Study”. Journal of Neuro-oncology. Springer Science and Business Media LLC. doi:10.1007/s11060-017-2533-6.

clinicaltrials.govStudy

Lapatinib With Temozolomide and Regional Radiation Therapy for Patients With Newly-Diagnosed Glioblastoma Multiforme

2012. "Lapatinib With Temozolomide and Regional Radiation Therapy for Patients With Newly-Diagnosed Glioblastoma Multiforme". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01591577.

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