Status:
WITHDRAWN
Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
Lead Sponsor:
Yale University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Paget's Disease of the Vulva
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
The primary objective will be to estimate the anti-tumor activity of trastuzumab by evaluating the response to trastuzumab therapy in patients with recurrent or persistent vulvar Paget's disease demon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01427244
Start Date
August 1 2011
End Date
September 1 2015
Last Update
June 16 2014
Active Locations (1)
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1
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06520