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

NCT ID: NCT00872482

Last Updated: 2011-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-07-31

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 cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.

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, unacceptable toxicity or at the discretion of the physician. Randomization will be done 2:1 (experimental:control). Chemotherapy can be added before documented disease progression at the discretion of the physician.

The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT. The primary endpoint is intracranial disease progression over 6 months.

The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at 6 months; time to intracranial disease progression; and time to overall progression.

Tissue samples and serum will be collected for future correlative studies.

All the images will be centrally reviewed at the end of study.

Conditions

Metastatic Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Nimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT. Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.

Group Type: EXPERIMENTAL

nimotuzumab

Intervention Type: DRUG

Nimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.

2

A placebo will be administered by the intravenous route weekly during WBRT and following WBRT.

Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.

Group Type: PLACEBO_COMPARATOR

nimotuzumab

Intervention Type: DRUG

Nimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.

Interventions

nimotuzumab

Nimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CIMYM BioSciences

OTHER

Sponsor Role: collaborator

YM BioSciences

INDUSTRY

Sponsor Role: lead

Responsible Party

YM BioSciences

Principal Investigators

Anthony Brade, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assitant Professor, Department of Radiation Oncology, University of Toronto

Locations

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

Countries

United States; Canada; Cuba; Pakistan; South Korea

Other Identifiers

YMB1000-018

Identifier Type: -

Identifier Source: org_study_id