None listed
Conditions
Brief summary
This study looks at the effectiveness of the drug nimotuzumab in treating people with brain cancer which has spread (metatstases) from non-small cell lung cancer (NSCLC). Who is it for? You can join this study if you have NSCLC and it has spread to the brain where it is not suitable for surgical removal. Trial details Participants will be divided into two groups. One group will receive whole brain radiation therapy (WBRT) in combination with intravenous nimotuzumab administered weekly during radiotherapy and following radiotherapy. The other group will receiver WBRT in combination with a non-active compound (placebo). Treatment and monitoring continues until any progression of disease or unacceptable side effects. Participants will be assessed by laboratory tests, imaging studies, standardized neurologic examination, and neurologic symptoms. Brain metastases are found in 20% to 40% of adult patients with cancer and the current standard treatment is WBRT alone. New therapies are needed, and the current study aims to evaluate the effectiveness of nimotuzumab in treating the disease.
Interventions
Nimotuzumab [or h-R3, a humanized monoclonal antibody against Epidermal growth factor receptor (EGFR)] 200 mg or placebo will be diluted in a final volume of 250mL (isotonic)saline solution and administered by the intravenous route over 30 minutes weekly during radiotherapy and following whole brain radiation therapy (WBRT) until disease progression, unacceptable toxicity or withdrawal of consent. WBRT will consist of 30 Gy, in 10 fractions of 3 Gy/day over 2 weeks (5 day per week). Patients wil
Nimotuzumab [or h-R3, a humanized monoclonal antibody against Epidermal growth factor receptor (EGFR)] 200 mg or placebo will be diluted in a final volume of 250mL (isotonic)saline solution and administered by the intravenous route over 30 minutes weekly during radiotherapy and following whole brain radiation therapy (WBRT) until disease progression, unacceptable toxicity or withdrawal of consent. WBRT will consist of 30 Gy, in 10 fractions of 3 Gy/day over 2 weeks (5 day per week). Patients will be assessed by laboratory tests, imaging studies, standardized neurologic examination, and neurologic symptoms.
Sponsors
YM BioSciences Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Providing a written informed consent 2. Age >=18 years; 3. Histologic or cytologic confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) of any epithelial type (squamous, adenocarcinoma, large cell, or other); 4. At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain not suitable for surgical resection 5. Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration 6. Karnofsky performance status (KPS) >=70; 7. Absolute neutrophil count >= 1500/mm^3; 8. Platelet count >= 50,000/mm^3; 9. Serum creatinine <=2.0 mg/dL; 10. Serum transaminases <=2 x the upper limit of normal (ULN); 11. Total serum bilirubin <=2 x ULN; 12. Lactate dehydrogenase (LDH) level <=1.3 x ULN. 13. Women of childbearing potential and men must agree to use adequate contraception (hormonal, or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately
Exclusion criteria
1. Pregnancy, lactation or parturition within the previous 30 days. 2. Previous WBRT. 3. Brain metastases resection with no other measurable lesion remaining. 4. Extracranial metastases in two or more organs. 5. Known leptomeningeal or subarachnoid tumor spread. 6. Plan to use radiosurgery or radiation boost after completion of WBRT. 7. Plan to use chemotherapy or any other antineoplastic modality during WBRT. 8. Previous use of an anti-EGFR drug (e.g. Tarceva, Erbitux etc.). 9. Patients receiving any other investigational agents. 10. Presence of known seropositive Human immunodeficiency virus (HIV). 11. Severe comorbidities, or other malignant neoplasm within 5 years (except adequately treated basal- or squamous-cell carcinoma of skin or in situ carcinoma of the uterine cervix). 12. Hypersensitivity or allergy to any of the drugs to be administered in this study. 13. Inability or unwillingness to complete the required assessments. 14. Geographic inaccessibility for treatment or follow-up evaluations.
Outcome results
None listed