Overview
A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases
Status:
Terminated
Terminated
Trial end date:
2011-07-01
2011-07-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
YM BioSciencesCollaborator:
CIMYM BioSciencesTreatments:
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.