NCT00826241

Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma

A Phase II Study of Dose-Dense Temozolomide and Lapatinib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if lapatinib when given in combination with temozolomide can help to control ependymoma that has come back after treatment. The safety of this combination will also be studied.

Detailed description

The Study Drugs: Temozolomide is designed to kill cancer cells by damaging deoxyribonucleic acid (DNA) (the genetic material of cells). This could cause the tumor cells to die. Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the human epidermal growth factor receptor 2 (Her2/neu) receptor and the epidermal growth factor receptor (EGFR). Study Drug Administration: If you are found to be eligible to take part in this study, every day, you will take lapatinib by mouth once a day in the morning. You should take lapatinib 1 hour before or 1 hour after eating, with at least 1 cup (about 8 oz.) of water. On Days 1-7 and 15-21 of each cycle, you will take temozolomide by mouth 1 time each day. You will start to take a lower dose of temozolomide for the first 2 cycles, then take a higher dose for Cycles 3 and beyond if you tolerate the treatment. It should be taken at least 2 hours before and 2 hours after eating with 1 cup (about 8 oz.) of water. You should swallow temozolomide and/or lapatinib whole, one right after the other, without chewing either of the study drugs. If you vomit while taking temozolomide and lapatinib, you cannot take more capsules before the next scheduled dose. You should report any missed pills or trouble you have with taking the pills to your study doctor. Your study doctor will give you a form (patient diary) to fill out to keep track of your treatment. You will be asked to return your completed diary and pill bottles at each visit with your doctor. Each study "cycle" is 28 days. Study Visits: Every 2 weeks, blood (about 2-3 teaspoons) will be drawn for routine tests and to check your blood's ability to clot. Every 8 weeks, the following tests and procedures will be performed: * You will have a physical exam, including measurement of your vital signs. * You will have a neurological exam. * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * You will complete the quality of life questionnaire. * You will have an magnetic resonance imaging (MRI) scan to check the status of the disease. * You will have either a multi-gated acquisition scan (MUGA) scan (if the doctor thinks it is needed) or an echocardiogram. Length of Study: You will be on study treatment for up to 2 years. You will be taken off study treatment early if the disease gets worse or you experience intolerable side effects. After you are off study, you may be able to continue taking lapatinib for as long as the doctor thinks it is in your best interest. Your doctor will discuss this with you. End-of-Study Visit: After you go off study treatment, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed: * You will have a physical exam. * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * You will have a neurological exam. * Blood (about 3 teaspoons) will be drawn for routine tests and to check your blood's ability to clot. * You will complete the questionnaire. * You will have an MRI scan to check the status of the disease. * You will have either a MUGA scan (if the doctor thinks it is needed) or an echocardiogram. Long-Term Follow-up Visit: If you go off treatment (having completed the maximum 24 months on study drug treatment) and have stable disease or response, you will have an MRI scan to check the status of the disease every 2 months for first year after you are off study, then every 3 months for the second year, then every 4 months for the third year, and then every 6 months from then on. If you continue taking lapatinib after you have completed up to 24 months on study treatment, you will have a clinic visit and an MRI scan to check the status of the disease every 2 months for as long as the doctor thinks it is needed. At the clinic visits, you will be asked how you are doing. If you went off study treatment because the disease got worse or you experienced intolerable side effects, after the end-of-study visit, the study staff will call you every 3 months from then on to check how you are doing. Each phone call will take about 5 minutes. This is an investigational study. Temozolomide is Food and Drug Administration (FDA) approved or commercially available for the treatment of tumors of the nervous system. Lapatinib is FDA approved and commercially available for the treatment of breast cancer. However, lapatinib is not FDA approved for the treatment of brain tumors. The use of lapatinib with temozolomide in the treatment of brain tumors and spinal tumors is investigational. Up to 50 patients will take part in this multicenter study. Up to 30 will be enrolled at MD Anderson.

Conditions

• Brain Tumors
• Spinal Cord Tumors

Interventions

Type	Name	Description
DRUG	Temozolomide	Starting dose 125 mg/m\^2 daily by mouth on days 1-7 \& 15-21 of a 28 day cycle.
DRUG	Lapatinib	Starting dose 1250 mg daily by mouth.

Timeline

• Start date: 2009-01-01
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2009-01-22
• Last updated: 2019-03-22
• Results posted: 2019-03-22

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study