Clinical Trial: NCT02571530 - My Cancer Genome

NCT02571530

Description:

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.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02571530

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: 15-312
NCT ID: NCT02571530

Conditions

Neoplasm Metastasis

Interventions

Drug	Synonyms	Arms
Intra-arterial Cerebral Infusion of Trastuzumab		Intra-arterial Cerebral Infusion of Trastuzumab

Purpose

Trial Arms

Name	Type	Description	Interventions
Intra-arterial Cerebral Infusion of Trastuzumab	Experimental	Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption	Intra-arterial Cerebral Infusion of Trastuzumab

Eligibility 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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Maximum tolerated dose (MTD)
Time Frame:	30 days
Safety Issue:
Description:	Maximum tolerated dose (MTD) the highest dose at which there are no dose limiting toxicities.

Secondary Outcome Measures

Measure:	Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame:	1 year
Safety Issue:
Description:	RECIST Criteria

Measure:	Overall Survival (OS)
Time Frame:	1 year
Safety Issue:
Description:

Measure:	Intracranial Time to Progression
Time Frame:	1 year
Safety Issue:
Description:

Details

Phase:	Phase 1
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Northwell Health

Last Updated

September 10, 2020

Clinical Trials /

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