We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified November 2016 by John A. Boockvar, Northwell Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT02571530
First Posted: October 8, 2015
Last Update Posted: November 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
John A. Boockvar, Northwell Health
  Purpose

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.


Condition Intervention Phase
Neoplasm Metastasis Drug: Intra-arterial Cerebral Infusion of Trastuzumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by John A. Boockvar, Northwell Health:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Study Start Date: September 2015
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-arterial Cerebral Infusion of Trastuzumab
Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption
Drug: Intra-arterial Cerebral Infusion of Trastuzumab

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571530


Contacts
Contact: John Boockvar, MD 212-434-3900
Contact: Tamika Wong, MPH 212-434-4836 twong4@nshs.edu

Locations
United States, New York
Lenox Hill Brain Tumor Center Recruiting
New York, New York, United States, 10075
Contact: John Boockvar, MD    212-434-3900      
Contact: Tamika Wong, MPH    212-434-4836    twong4@nshs.edu   
Principal Investigator: John Boockvar, MD         
Sub-Investigator: Jonathan Knisely, MD         
Sub-Investigator: David Langer, MD         
Sub-Investigator: Rafael Ortiz, MD         
Sub-Investigator: Sherese Fralin, NP         
Sub-Investigator: Ashley Ray, NP         
Sub-Investigator: Karissa Tan, NP         
Sub-Investigator: Tamika Wong, MPH         
Sponsors and Collaborators
Northwell Health
  More Information

Responsible Party: John A. Boockvar, Professor, Northwell Health
ClinicalTrials.gov Identifier: NCT02571530     History of Changes
Other Study ID Numbers: 15-312
First Submitted: September 16, 2015
First Posted: October 8, 2015
Last Update Posted: November 4, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Trastuzumab
Antineoplastic Agents


To Top