Paget's Disease of the Vulva Clinical Trial
Official title:
A Phase II Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
| Verified date | June 2014 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University | Genentech, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | measurement of the longest diameter for all target lesions | Where possible measurement of the target lesion size in 2 perpendicular diameters will be required for follow up. A Change in the product of these 2 diameters affords some estimate of change in tumor size and hence therapeutic efficacy. Response criteria will be based on the RECIST modified response evaluation criteria (appendix I).The reporting of these changes will be on an individual case basis and will be in terms of the best response achieved by that case. | 5 years | Yes |
| Secondary | To assess the safety profile of trastuzumab in persistent or recurrent vulvar Paget's disease | To assess the safety profile for all patients who receive any amount of trastuzumab will be evaluable for toxicity.At each visit, a brief focused history will be obtained and any indication of treatment related toxicity will be evaluated by appropriate examination and/or laboratory/radiographic studies using the CTCAE v4.0 toxicity grades for both laboratory and non-laboratory data.The evaluation period should extend from date of first treatment until 30 days (or longer if so specified) from the last dose, or until resolution from all acute toxicities associated with the drug administration. | 5 years | Yes |