Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byJeffrey Raizer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Age > 18 years

KPS > 50

ELIGIBILITY CRITERIA

See 7 more

Treatment Details

Interventions

Trastuzumab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: intravenous trastuzumab infusionsExperimental Treatment1 Intervention

A Phase I single dose study (H0407g) of intravenous trastuzumab infusions ranging from 10-500 mg resulted in dose-dependent pharmacokinetics (PK) with serum clearance of trastuzumab decreasing with an increasing dose at doses \<250 mg. PK modeling of trastuzumab concentration-time data from 7 patients that were administered doses of 250 mg and 500 mg had in a mean halflife of 5.8 days (range 1-32 days).

Trastuzumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Herceptin for: