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

NCT00872482 | Terminated Phase 2

• 1 other identifier: YMB1000-018
• Study Type: interventional
• Target: 21
• Locations: 5 countries
• Sites: 15

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.

Conditions

Metastatic Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer; NSCLC; Brain metastases; nimotuzumab; TheraCIM; h-R3; Radiation

Outcome Measures

Primary Outcomes (1)

• Phase II: efficacy.Withhold of intracranial progression at 2, 4 and 6 months in comparison with control arm. Patients will be assessed by lab tests, MRI,neurologic examination

  weekly infusions during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or withdrawal of consent.

Secondary Outcomes (1)

• 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.

  1 year

Study Arms (2)

1

EXPERIMENTAL

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.

Drug: nimotuzumab

2

PLACEBO COMPARATOR

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.

Drug: nimotuzumab

Interventions

nimotuzumab 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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• YM BioSciences: lead
• CIMYM BioSciences: collaborator

Study Sites (15)

Florida Cancer Institute - New Hope

New Port Richey, Florida, 34655, United States

Location

Park Nicollet Institute - Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426, United States

Location

Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

Tom Baker Cancer Center

Calgary, Alberta, T2N4N2, Canada

Location

Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

London Regional Cancer Center

London, Ontario, N6A-4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G-2M9, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T-2M4, Canada

Location

Hotel Dieu Hospital

Québec, Quebec, G1H 2J6, Canada

Location

Hospital Clínico Quirúrgico Hermanos Ameijeiras

Centro Habana, La Habana, Cuba

Location

Hameed Latif Hospital, Lahore (HLH)

Town, Lahore, Pakistan

Location

Nuclear Medicine and Radiation Oncology Institute (NORI)

Islamabad, Pakistan

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anthony Brade, M.D.

  Assitant Professor, Department of Radiation Oncology, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 31, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 1, 2011

Record last verified: 2011-06

Locations

US (3); PA (2); KR (1); CA (8); CU (1)