A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases
Stopped early · Phase 2
Conditions studied: Metastatic Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT00872482
- Run by
- YM BioSciences
- People needed
- 21
- Starts
- 2009-04-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2011-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Florida Cancer Institute - New Hope — New Port Richey, Florida, United States
- Park Nicollet Institute - Frauenshuh Cancer Center — Saint Louis Park, Minnesota, United States
- Overlake Hospital Medical Center — Bellevue, Washington, United States
- Tom Baker Cancer Center — Calgary, Alberta, Canada
- Cancer Centre for the Southern Interior — Kelowna, British Columbia, Canada
- Dr. H. Bliss Murphy Cancer Centre — St. John's, Newfoundland and Labrador, Canada
- Royal Victoria Hospital — Barrie, Ontario, Canada
- London Regional Cancer Center — London, Ontario, Canada
- Princess Margaret Hospital — Toronto, Ontario, Canada
- Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada
- Hotel Dieu Hospital — Québec, Quebec, Canada
- Hospital Clínico Quirúrgico Hermanos Ameijeiras — Centro Habana, La Habana, Cuba
- Hameed Latif Hospital, Lahore (HLH) — Town, Lahore, Pakistan
- Nuclear Medicine and Radiation Oncology Institute (NORI) — Islamabad, Pakistan
- Severance Hospital — Seoul, South Korea
Full record on ClinicalTrials.gov
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