NCT01591577

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

Completed Phase 2 Last updated 16 May 2024

What this trial tests

Phase 2 trial testing Lapatinib/Temozolomide/radiation in Newly Diagnosed Glioblastoma Multiforme in 50 participants. Completed in 7 May 2024.

Timeline

7 December 2012

Primary endpoint
7 May 2024

7 May 2024

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	7 December 2012
Primary completion	7 May 2024
Estimated completion	7 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Lapatinib/Temozolomide/radiation

Conditions studied

• Newly Diagnosed Glioblastoma Multiforme — all drugs for Newly Diagnosed Glioblastoma Multiforme →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Newly Diagnosed Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to test the safety and effects of a combination of a study drug, Lapatinib, plus the administration of standard radiation therapy and an FDA approved drug Temozolomide (chemotherapy agent) in patients with newly diagnozed glioblastoma Multiforme.Currently, only radiation therapy and Temozolomide chemotherapy are standard treatment for brain cancer.Lapatinib has not been FDA approved for use in brain tumors treatment. It has been approved to be used as a daily treatment with other chemotherapies by the FDA for the treatment of advanced breast cancer.

The purpose of this study is to find the answers to the following research questions:

1. Is Lapatinib given twice a week at higher dosages, with radiation therapy and Temozolomide, safe when given to patients with brain tumor?
2. What are the side effects of Lapatinib given twice a week at higher dosages when given with radiation therapy and Temozolomide and how often do they occur?
3. Can Lapatinib, radiation, and Temozolomide be effective in shrinking tumors when given to patients with brain tumors?
4. To determine whether the presence of genetic alterations specific proteins in the tumor samples can predict whether this study drug is effective on the tumor.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Challenges and Opportunities in Treating Glioblastoma.
   Shergalis A, Bankhead A, Luesakul U, Muangsin N, et al · · 2018 · cited 612× · PMID 29669750 · DOI 10.1124/pr.117.014944
2. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
3. Targeting cellular pathways in glioblastoma multiforme.
   Pearson JRD, Regad T. · · 2017 · cited 231× · PMID 29263927 · DOI 10.1038/sigtrans.2017.40
4. EGFR heterogeneity and implications for therapeutic intervention in glioblastoma.
   Eskilsson E, Røsland GV, Solecki G, Wang Q, et al · · 2018 · cited 228× · PMID 29040782 · DOI 10.1093/neuonc/nox191
5. Phase I/randomized phase II study of afatinib, an irreversible ErbB family blocker, with or without protracted temozolomide in adults with recurrent glioblastoma.
   Reardon DA, Nabors LB, Mason WP, Perry JR, et al · · 2015 · cited 135× · PMID 25140039 · DOI 10.1093/neuonc/nou160
6. Updated Insights on EGFR Signaling Pathways in Glioma.
   Oprita A, Baloi SC, Staicu GA, Alexandru O, et al · · 2021 · cited 111× · PMID 33435537 · DOI 10.3390/ijms22020587
7. A Systematic Review of Glioblastoma-Targeted Therapies in Phases II, III, IV Clinical Trials.
   Cruz Da Silva E, Mercier MC, Etienne-Selloum N, Dontenwill M, et al · · 2021 · cited 99× · PMID 33918704 · DOI 10.3390/cancers13081795
8. Targeted molecular therapies against epidermal growth factor receptor: past experiences and challenges.
   Reardon DA, Wen PY, Mellinghoff IK. · · 2014 · cited 80× · PMID 25342602 · DOI 10.1093/neuonc/nou232