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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00872482
Other study ID # YMB1000-018
Secondary ID
Status Terminated
Phase Phase 2
First received March 26, 2009
Last updated June 30, 2011
Start date April 2009
Est. completion date July 2011

Study information

Verified date June 2011
Source YM BioSciences
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaCanada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 21
Est. completion date July 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Canada Royal Victoria Hospital Barrie Ontario
Canada Tom Baker Cancer Center Calgary Alberta
Canada Cancer Centre for the Southern Interior Kelowna British Columbia
Canada London Regional Cancer Center London Ontario
Canada Hopital Maisonneuve-Rosemont Montreal Quebec
Canada Hotel Dieu Hospital Quebec City Quebec
Canada Dr. H. Bliss Murphy Cancer Centre St. John's Newfoundland and Labrador
Canada Princess Margaret Hospital Toronto Ontario
Cuba Hospital Clínico Quirúrgico Hermanos Ameijeiras Centro Habana La Habana
Korea, Republic of Severance Hospital Seoul
Pakistan Nuclear Medicine and Radiation Oncology Institute (NORI) Islamabad
Pakistan Hameed Latif Hospital, Lahore (HLH) Town Lahore
United States Overlake Hospital Medical Center Bellevue Washington
United States Florida Cancer Institute - New Hope New Port Richey Florida
United States Park Nicollet Institute - Frauenshuh Cancer Center St. Louis Park Minnesota

Sponsors (2)

Lead Sponsor Collaborator
YM BioSciences CIMYM BioSciences

Countries where clinical trial is conducted

United States,  Canada,  Cuba,  Korea, Republic of,  Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Yes
Secondary 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 No
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