NCT00107003

GW572016 to Treat Recurrent Malignant Brain Tumors

Completed Phase 2 Last updated 5 July 2018

What this trial tests

Phase 2 trial testing lapatinib ditosylate in Glioma in 9 participants. Completed in 30 November 2012.

Timeline

30 March 2005

Primary endpoint
5 December 2007

30 November 2012

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	30 March 2005
Primary completion	5 December 2007
Estimated completion	30 November 2012
Sites	1 location across United States

Drugs / interventions tested

• lapatinib ditosylate — full drug profile →
• Adjuvant therapy — full drug profile →
• Conventional surgery
• Neoadjuvant therapy — full drug profile →

Conditions studied

• Glioma — all drugs for Glioma →
• Brain Tumor — all drugs for Brain Tumor →
• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
• GBM — all drugs for GBM →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Glioma or Brain Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine whether an experimental drug called GW572016 can delay tumor growth in patients with glioblastoma multiforme (GMB, a malignant brain tumor). GW572016 is believed to affect cancer cell function by interfering with the internal signaling needed for the cancer to grow. The study will also determine whether the presence of specific proteins in the tumor can predict what effects GW572016 will have on the tumor.

Patients 18 years of age and older with GMB whose brain tumor does not respond to standard medical treatment and who can undergo surgery for their tumor may be eligible for this study. Candidates are screened with a physical examination and neurocognitive examination, blood tests, electrocardiogram (EKG), echocardiogram (ultrasound test of heart function) or MUGA scan (nuclear medicine test of heart function), magnetic resonance imaging (MRI) of the head, and computed tomography (CT) of the head. CT uses x-rays and MRI uses a magnetic field and radio waves to show brain structure.

Participants undergo the following tests and procedures:

* MRI and blood tests before surgery.
* Surgery to remove the brain tumor.
* Follow-up MRIs every 8 weeks after surgery.
* Follow-up echocardiograms or MUGA scans every 8 weeks after surgery.
* GW572016 treatment starting 7-10 days before surgery and continuing until the patient or doctor decides it is in the patient's best interest to stop it or until the tumor worsens. (The drug is stopped temporarily for surgery and a healing period after surgery.)
* Blood tests every 2 weeks to evaluate the effects of GW572016 on the body.
* Blood test before the first GW572016 treatment and at the time of surgery to assess the effect of the drug on the cells and to determine how much drug is present in the blood at the time of surgery.

Participants are followed in clinic at least monthly while taking GW572016. While on treatment they keep a diary documenting their daily treatments. The diary is collected at the monthly follow-up exams. After the treatment ends, patients are contacted periodically by the research staff for the rest of their lives to follow the long-term effects of the study.

Publications & conference data

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

1. PI3K/Akt/mTOR signaling pathway and targeted therapy for glioblastoma.
   Li X, Wu C, Chen N, Gu H, et al · · 2016 · cited 406× · PMID 26967052 · DOI 10.18632/oncotarget.7961
2. Targeting RTK-PI3K-mTOR Axis in Gliomas: An Update.
   Colardo M, Segatto M, Di Bartolomeo S. · · 2021 · cited 102× · PMID 34063168 · DOI 10.3390/ijms22094899
3. 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
4. The Molecular and Microenvironmental Landscape of Glioblastomas: Implications for the Novel Treatment Choices.
   Di Cintio F, Dal Bo M, Baboci L, De Mattia E, et al · · 2020 · cited 28× · PMID 33324155 · DOI 10.3389/fnins.2020.603647