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

• Status: Withdrawn
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Genentech, Inc.
• Treatments: Trastuzumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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