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

Primary Purpose

Metastatic Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nimotuzumab
Sponsored by
YM BioSciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Non-Small Cell Lung Cancer focused on measuring non-small cell lung cancer, NSCLC, Brain metastases, nimotuzumab, TheraCIM, h-R3, Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Cancer Institute - New Hope
  • Park Nicollet Institute - Frauenshuh Cancer Center
  • Overlake Hospital Medical Center
  • Tom Baker Cancer Center
  • Cancer Centre for the Southern Interior
  • Dr. H. Bliss Murphy Cancer Centre
  • Royal Victoria Hospital
  • London Regional Cancer Center
  • Princess Margaret Hospital
  • Hopital Maisonneuve-Rosemont
  • Hotel Dieu Hospital
  • Hospital Clínico Quirúrgico Hermanos Ameijeiras
  • Severance Hospital
  • Hameed Latif Hospital, Lahore (HLH)
  • Nuclear Medicine and Radiation Oncology Institute (NORI)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 26, 2009
Last Updated
June 30, 2011
Sponsor
YM BioSciences
Collaborators
CIMYM BioSciences
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1. Study Identification

Unique Protocol Identification Number
NCT00872482
Brief Title
A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases
Official Title
A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
Study closed due to low enrollment
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
YM BioSciences
Collaborators
CIMYM BioSciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non-Small Cell Lung Cancer
Keywords
non-small cell lung cancer, NSCLC, Brain metastases, nimotuzumab, TheraCIM, h-R3, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
nimotuzumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
weekly infusions during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or withdrawal of consent.
Secondary Outcome Measure Information:
Title
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Brade, M.D.
Organizational Affiliation
Assitant Professor, Department of Radiation Oncology, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Cancer Institute - New Hope
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Park Nicollet Institute - Frauenshuh Cancer Center
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Overlake Hospital Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N2
Country
Canada
Facility Name
Cancer Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Dr. H. Bliss Murphy Cancer Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
London Regional Cancer Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A-4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G-2M9
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T-2M4
Country
Canada
Facility Name
Hotel Dieu Hospital
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1H 2J6
Country
Canada
Facility Name
Hospital Clínico Quirúrgico Hermanos Ameijeiras
City
Centro Habana
State/Province
La Habana
Country
Cuba
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hameed Latif Hospital, Lahore (HLH)
City
Town
State/Province
Lahore
Country
Pakistan
Facility Name
Nuclear Medicine and Radiation Oncology Institute (NORI)
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

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

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