A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.

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

Details

• Lead Sponsor: YM BioSciences
• Collaborator: CIMYM BioSciences
• Treatments: Nimotuzumab

Criteria

Inclusion Criteria:

• Providing a written informed consent (see Appendix A);

• Age ≥18 years;

• Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other);

• At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain;

• Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration

• KPS ≥70;

• Absolute neutrophil count ≥ 1500/mm³;

• Platelet count ≥ 50,000/mm³;

• Serum creatinine ≤2.0 mg/dL;

• Serum transaminases ≤2 x the upper limit of normal (ULN);

• Total serum bilirubin ≤2 x ULN;

• And a lactate dehydrogenase (LDH) level ≤1.3 x ULN.

Exclusion Criteria:

• Pregnancy, lactation or parturition within the previous 30 days (fertile female or male patients should practice contraception);

• Prior WBRT, brain metastases resection with no other measurable lesion remaining;

• Extracranial metastases in two or more organs;

• Known leptomeningeal or subarachnoid tumor spread;

• Plan to use radiosurgery or radiation boost after completion of WBRT;

• Plan to use chemotherapy or any other systemic antineoplastic modality during WBRT;

• Previous use of an anti-EGFR drug;

• Participation in another ongoing therapeutic trial;

• Presence of known HIV seropositivity, 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);

• Hypersensitivity or allergy to any of the drugs to be administered in this study;

• Inability or unwillingness to complete the required assessments;

• Geographic inaccessibility for treatment or follow-up evaluations.