A Phase II Multi-center Pilot Study of Concurrent Temozolomide and Whole Brain Irradiation in Lung Cancer and Breast Cancer Patients With Brain Metastases

A Phase II, Open-label, Single-arm, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Whole-brain Radiotherapy With Concomitant Temozolomide in Lung Cancer and Breast Cancer Patients With Brain Metastases

Brain metastasis (BM) is among the most feared complications in cancer because even small tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ) is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus concomitant TMZ in lung cancer and breast cancer patients with BM.

Inclusion Criteria:

• Histologically or cytologically confirmed lung cancer or breast cancer at primary site
• Patient with inoperable brain metastases
• Female or male, ≥ 20 and < 65 years of age
• Karnofsky performance status (KPS) ≥ 70%
• Life expectancy ≥ 12 weeks
• Adequate organ function
• Willing and able to provide a written informed consent

Exclusion Criteria:

• Female of childbearing potential* who is pregnant/lactating or planning to be pregnant
• Male whose partner is planning to be pregnant
• Inability to swallow
• Meningeal carcinomatosis
• History of hypersensitivity to iodinated contrast media, temozolomide or any component of the study drugs
• Prior use of temozolomide
• Use of systemic chemotherapy within 2 weeks prior to the initiation of study treatment
• Prior surgery, chemotherapy or radiotherapy for a brain neoplasm
• Current use of valproic acid
• Use of any investigational product within 4 weeks prior to the initiation of study treatment
• Patient with any condition or disease which is considered not suitable for this study by investigator