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Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Trastuzumab (Radiation)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Jeffrey Raizer, MD, Principal Investigator, Affiliation: Northwestern University

Overall contact:
Jeffrey Raizer, MD, Phone: 312-695-0990, Email: Jraizer@nmff.org

Summary

The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive. Patients are being asked to participate in this study because they have been diagnosed with having tumor cells in their spinal fluid. This study will investigate the safety and effects of this drug when given directly into the spinal fluid. Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer The purpose of this research study is to determine a safe dose of the drug Trastuzumab and then determine how effective this treatment is.

Clinical Details

Official title: Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determine the safety and maximum tolerated dose of IT trastuzumab.

Secondary outcome:

Determine response to IT trastuzumab: radiological, cytological and clinical.

Define the CSF PK of IT trastuzumab.

Detailed description: Phase I: Patients will be treated in cohorts of 3-6 based on standard phase I dose escalation parameters requiring 0/3 or 1/6 patients per cohort to have a DLT before dose escalation. Dosing is as follows: Cohort 1-10 mg IT, cohort 2-20 mg IT, cohort 3-30 mg IT and cohort 4-40 mg IT. Patients will be treated twice a week for 4 weeks, then once a week for 4 weeks, and then every 2 weeks. Toxicity for DLT will be assessed during first 4 weeks of treatment. Phase II: Patients will be treated with the MTD or maximal defined dose. Patients will be treated twice a week for 4 weeks, then once a week for 4 weeks, and then every 2 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: ELIGIBILITY CRITERIA

- HER2 positive (IHC 3+ and/or FISH positive) breast cancer patients with

leptomeningeal metastases by MRI or CSF (if MRI is negative). o Review will be performed for cases not reviewed at Northwestern for confirmation, but will not preclude patients from entering the trial (pathology report is sufficient for registration).

- Patients can have concomitant brain metastases as long as they do not require active

treatment or have been treated.

- Patients with leptomeningeal disease from ependymomas, gliomas, and medulloblastoma

will be eligible for phase I

- Life expectancy > 8 weeks

- Normal renal (creatinine < 1. 5 ULN), liver (bilirubin < 1. 5 x ULN, transaminases <

3. 0 x ULN, except in known hepatic metastasis, wherein may be < 5 x ULN) and blood counts (WBC > 3. 0, Neutrophils > 1500, platelets >100 000, Hemoglobin > 10).

- LVEF > 50%

- KPS > 50

- Age > 18 years

- Cannot be on systemic agents (chemotherapy) that have CNS penetration unless they

develop leptomeningeal metastases while on these agent(s) and have controlled systemic disease. May continue on IV trastuzumab, lapatinib or hormonal agents if controlling systemic disease and developed LM while on therapy. Patients requiring systemic chemotherapy are eligible but will not be able to start treatment until after the first assessment by imaging and cytology.

- Patients may need a CSF flow study at the discretion of the treating principal

investigator. If a spinal block is seen by CSF flow study or MRI, it will need local RT prior to treatment. Concurrent radiation is not allowed.

- Patients should be > 2 weeks from RT treatment and all effects of treatment should

have resolved

- No limit on prior systemic or IT therapies.

- CSF sampling to document LM if not documented on MRI.

- Must be willing to have an Ommaya reservoir placed.

- NO history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ

of the cervix) unless in complete remission and off all therapy for the disease for a minimum of 3 years.

- Significant medical or psychiatric illness that would interfere with compliance and

ability to tolerate treatment as outlined in the protocol.

- Women of childbearing potential and sexually active males must commit to the use of

effective contraception while on study.

- Women may not be pregnant or breast-feeding.

- Ability to sign an informed consent; can be signed by family member or health care

proxy. Informed consent must be done prior to registration on study.

- All patients must have given signed, informed consent prior to registration on study.

- No known hypersensitivity to trial medications Note: The eligibility criteria listed

above are interpreted literally and cannot be waived. Exclusion Criteria:

- Any deviations from the inclusion criteria

Locations and Contacts

Jeffrey Raizer, MD, Phone: 312-695-0990, Email: Jraizer@nmff.org

University of California San Francisco (UCSF), San Francisco, California 94143-1710, United States; Recruiting
Michelle Melisko, MD, Phone: 415-353-7070
Michelle Melisko, MD, Principal Investigator

Northwestern University, Chicago, Illinois 60611, United States; Recruiting

Dana Farber Cancer Institute, Boston, Massachusetts 02215, United States; Recruiting
Nancy Lin, MD, Email: nancy_lin@dfci.harvard.edu
Nancy Lin, MD, Principal Investigator

Columbia University, New York, New York 10032, United States; Recruiting
Teri N. Kreisl, MD, Phone: 212-342-0571
Teri N. Kreisl, MD, Principal Investigator

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Elena Pentsova, MD, Phone: 212-639-7330, Email: PentsovE@mskcc.org
Elena Pentsova, MD, Principal Investigator

Rhode Island Hospital, Providence, Rhode Island 02903, United States; Active, not recruiting

Texas Oncology-Austin, Austin, Texas 78705, United States; Recruiting
Morris Groves, MD, Phone: 512-421-4100
Morris D. Groves, M.D., Principal Investigator

Additional Information

Starting date: April 2011
Last updated: March 26, 2015

Page last updated: August 23, 2015

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