Status:
TERMINATED
A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases
Lead Sponsor:
YM BioSciences
Collaborating Sponsors:
CIMYM BioSciences
Conditions:
Metastatic Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 cel...
Detailed Description
A phase II, randomized, controlled, double blinded and multicenter study with 2 arms, administering the study drug during radiotherapy and following radiotherapy until disease progression, unacceptabl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00872482
Start Date
April 1 2009
End Date
July 1 2011
Last Update
July 1 2011
Active Locations (15)
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1
Florida Cancer Institute - New Hope
New Port Richey, Florida, United States, 34655
2
Park Nicollet Institute - Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426
3
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
4
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N4N2