A Phase II Multi-center Pilot Study of Concurrent Temozolomide and Whole Brain Irradiation in Lung Cancer and Breast Cancer Patients With Brain Metastases
Conditions
Lung Cancer and Breast Cancer Patients With Brain Metastases
Conditions: official terms
Brain Neoplasms - Breast Neoplasms - Lung Neoplasms - Neoplasm Metastasis
Conditions: Keywords
lung cancer and breast cancer patients with brain metastases
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: temozolomide 100mg
Type: Drug
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 20 Years
Gender: Both
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
Location
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Status: Not yet recruiting
Contact: Pei-Wei Shueng, MD - 886-2-8966-7000 - shueng@mail.femh.org.tw
Start Date
May 2014
Completion Date
May 2016
Sponsors
Far Eastern Memorial Hospital
Source
Far Eastern Memorial Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page