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

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ClinicalTrials.gov Identifier: NCT00872482
Recruitment Status : Terminated (Study closed due to low enrollment)
First Posted : March 31, 2009
Last Update Posted : July 1, 2011
Sponsor:
Collaborator:
CIMYM BioSciences
Information provided by:
YM BioSciences

Tracking Information
First Submitted Date  ICMJE March 26, 2009
First Posted Date  ICMJE March 31, 2009
Last Update Posted Date July 1, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00872482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Non-Small Cell Lung Cancer
Intervention  ICMJE 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.
Study Arms
  • Experimental: 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.
    Intervention: Drug: nimotuzumab
  • Placebo Comparator: 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.

    Intervention: Drug: nimotuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 30, 2011)
21
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2009)
80
Estimated Study Completion Date July 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Cuba,   Korea, Republic of,   Pakistan,   United States
Removed Location Countries Australia
 
Administrative Information
NCT Number  ICMJE NCT00872482
Other Study ID Numbers  ICMJE YMB1000-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wendy Chapman, Vice President, Clinical Operations, YM BioSciences
Study Sponsor  ICMJE YM BioSciences
Collaborators  ICMJE CIMYM BioSciences
Investigators  ICMJE
Principal Investigator: Anthony Brade, M.D. Assitant Professor, Department of Radiation Oncology, University of Toronto
PRS Account YM BioSciences
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP