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Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT02571530
Recruitment Status : Recruiting
First Posted : October 8, 2015
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
John Boockvar, MD Zucker SOM @Hofstra/Northwell, Northwell Health

Tracking Information
First Submitted Date  ICMJE September 16, 2015
First Posted Date  ICMJE October 8, 2015
Last Update Posted Date May 17, 2019
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • Maximum tolerated dose (MTD) [ Time Frame: 30 days ]
    Maximum tolerated dose (MTD) the highest dose at which there are no dose limiting toxicities.
  • Adverse events and dose-limiting toxicities [ Time Frame: 30 days ]
    A dose-limiting toxicity (DLT) will be defined as any grade 3 or 4 NCI Common Toxicity Criteria adverse event (CTCAE V4.0).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02571530 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 1 year ]
    RECIST Criteria
  • Overall Survival (OS) [ Time Frame: 1 year ]
  • Intracranial Time to Progression [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
Official Title  ICMJE Phase 1 Trial of Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
Brief Summary

The purpose of this study is to evaluate the safety of administering a single dose of trastuzumab into the artery for the treatment of brain metastasis(es) from HER2/neu positive breast cancer.

This study will try to determine the best tolerated single dosage of trastuzumab administered into arteries by gradually increasing the dosage given to participants as the study progresses. Early participants will receive a dosage of 1 mg/kg. As more participants enroll into the study, this single dosage will be increased at designated levels up to 8 mg/kg, if it's determined to be safe to increase.

Trastuzumab is a type of antibody, which is a protein used by the body's immune system to fight against pathogens such as bacteria and viruses. This antibody binds to cell receptors known as the HER2/neu tyrosine kinase receptor. These receptors are expressed in certain cancer subtypes such as breast cancer. By blocking signaling through this HER2/neu receptor, trastuzumab can slow down or stop the over-expression of the HER2/neu protein. Over-expression of HER2/neu has been shown to play a role in the development and progression of certain types of breast cancer. Therefore, by slowing down or stopping the expression of HER2/neu, investigators hope to slow down or stop the growth of metastasis(es) and increase the responsiveness to therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasm Metastasis
Intervention  ICMJE Drug: Intra-arterial Cerebral Infusion of Trastuzumab
Study Arms  ICMJE Experimental: Intra-arterial Cerebral Infusion of Trastuzumab
Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption
Intervention: Drug: Intra-arterial Cerebral Infusion of Trastuzumab
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2015)		 48
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female patients 18 years of age or older
  2. Karnofsky Performance Status (KPS) of 70 or higher
  3. Capable of giving informed consent or have an acceptable surrogate capable of giving consent of the subject's behalf
  4. Have a documented history of HER2/neu positive breast cancer that is 3+ on immunohistochemical staining or positive on fluorescent in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) and have evidence of parenchymal metastatic tumor(s) on brain imaging studies.
  5. Adequate labs for procedure with trastuzumab, including but not limited to White Blood Count (WBC), Hemoglobin, Hematocrit, Platelet Count, Prothrombin Time (PT), International Normalized Ratio (INR), Sodium, Potassium, Chloride, Glucose, Blood Urea Nitrogen (BUN), Serum Creatinine (CR)

Exclusion Criteria:

  1. Age less than 18 years
  2. KPS less than 70
  3. Brain metastases without history of HER2/neu positive breast cancer
  4. Leptomeningeal dissemination of brain metastases
  5. Pregnancy or refusal to use contraception during a 3 month period before and 7 month period after Intra-arterial (IA) trastuzumab administration
  6. Prior administration of intraarterial trastuzumab
  7. Subjects with inadequate baseline Left Ventricular Ejection Fraction (LVEF)
  8. Subjects with history of infusion reaction with trastuzumab
  9. Subjects who have had blood brain barrier (BBB) disruption with mannitol within 48 hours
  10. Subjects with evidence of midline shift or herniation
  11. Subjects with resectable brain metastases or whose cerebral tumors are amenable to stereotactic radio-surgery
  12. Subjects who have not progressed after therapy for brain metastases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John Boockvar, MD 212-434-3900
Contact: Tamika Wong, MPH 212-434-4836 twong4@nshs.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02571530
Other Study ID Numbers  ICMJE 15-312
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Boockvar, MD Zucker SOM @Hofstra/Northwell, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Northwell Health
Verification Date May 2019

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