Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
This study is currently recruiting participants.
Verified August 2011 by Yale University
Sponsor:
Yale University
Collaborator:
Genentech
Information provided by (Responsible Party):
Thomas J. Rutherford, Yale University
ClinicalTrials.gov Identifier:
NCT01427244
First received: August 31, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Paget's Disease of the Vulva |
Drug: trastuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- measurement of the longest diameter for all target lesions [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- To assess the safety profile of trastuzumab in persistent or recurrent vulvar Paget's disease [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 29 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Trastuzumab
Open Label
|
Drug: trastuzumab
monoclonal antibody
Other Name: trastuzumab
|
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 demonstrating HER2/neu overexpression by immunohistochemistry and/ or FISH ((fluorescence in situ hybridization).
The secondary objectives:
- To evaluate the quality of life, based on the severity of the patients' vulvar itching on a 4-point verbal rating scale from 0 to 3 (0=no itching, 1=mild itching/ bothersome, 2=moderate itching/ troublesome, 3=severe itching/ extremely troublesome) as well as on the severity of the patients' vulvar pain on a numeric pain scale from 0-10 (0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain).
- To assess the frequency and severity of observed adverse effects
- To assess the frequency/ incidence of HER2 in Paget's disease of the vulva
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427244
Contacts
| Contact: Thomas J. Rutherford, MD,PhD | 203-785-6301 | thomas.rutherford@yale.edu |
| Contact: Lisa Baker, RN,BSN,OCN | 203-785-6398 | lisa.baker@yale.edu |
Locations
| United States, Connecticut | |
| Smilow Cancer Hospital at Yale New Haven | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Thomas J. Rutherford, MD, PhD 203-785-6301 thomas.rutherford@yale.edu | |
| Contact: Lisa Baker, RN, BSN, OCN 203-785-6398 lisa.baker@yale.edu | |
| Principal Investigator: Thomas J. Rutherford, MD, PhD | |
Sponsors and Collaborators
Yale University
Genentech
Investigators
| Principal Investigator: | Thomas J. Rutherford, MD, PhD | Yale University |
More Information
No publications provided
| Responsible Party: | Thomas J. Rutherford, Professor Thomas Joseph Rutherford, MD,PhD, Yale University |
| ClinicalTrials.gov Identifier: | NCT01427244 History of Changes |
| Other Study ID Numbers: | 1004006704 |
| Study First Received: | August 31, 2011 |
| Last Updated: | August 31, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
HER2+ Histologic confirmation measurable disease HER2 positive |
HER2 overexpression persistent vulvar Paget's disease recurrent vulvar Paget's disease |
Additional relevant MeSH terms:
|
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013