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

• Status: Unknown status
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Far Eastern Memorial Hospital
• Treatments: Dacarbazine; Temozolomide

Criteria

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