Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/3/2017 |
| Start Date: | September 2015 |
| Contact: | John Boockvar, MD |
| Phone: | 212-434-3900 |
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
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.
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.
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
We found this trial at
1
site
New York, New York 10065
Principal Investigator: John Boockvar, MD
Phone: 212-434-3900
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