Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease

Withdrawn before enrolling · Phase 2

Conditions studied: Paget's Disease of the Vulva

In brief

This is a phase II open-label study of the activity and safety of trastuzumab in patients with vulvar Paget's disease with overexpression of HER2 on biopsy.

Key facts

Study ID

NCT01427244

Run by

Yale University

People needed

0

Starts

2011-08-01

Expected to finish

2015-09-01

Last updated by the study team

2014-06-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• recurrent or persistent vulvar Paget's disease with overexpression of HER2 by immunohistochemistry and or fluorescence in situ hybridization (FISH)
• Biopsy for histologic confirmation
• Measurable disease
• Karnofsky score of 50-100
• recovered from effects of recent surgery, radiotherapy, or chemotherapy
• free of active infection requiring antibiotics
• adequate bone marrow function,renal function,hepatic function,cardiac function,WOCBP-neg.serum pregnancy,meet requirements in section 7.0

You may not qualify if…

• no measurable disease
• tumors not HER2 positive by immunohistochemistry FISH
• prior therapy with any anti-HER2 monoclonal antibody preparation
• Karnofsky score of 0-40
• other invasive malignancies, with the exception of non-melanoma skin cancer
• Patients requiring supplemental oxygen
• unstable medical conditions in the opinion of the treating physician place them at unacceptably increased risk from trastuzumab therapy
• Patients with active or unstable cardiac disease, or myocardial infarction within 6 months

Where it is running

• Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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