WithdrawnPhase 2

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

United States0Started 2011-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

measurement of the longest diameter for all target lesions

Timeframe: 5 years

Trial details

NCT IDNCT01427244

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

View on ClinicalTrials.gov More Paget's Disease of the Vulva trials