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

NCT01427244 | Withdrawn Phase 2 DMC

• 1 other identifier: 1004006704
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Paget's Disease of the Vulva

Keywords

HER2+; Histologic confirmation; measurable disease; HER2 positive; HER2 overexpression; persistent vulvar Paget's disease; recurrent vulvar Paget's disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To assess the safety profile of trastuzumab in persistent or recurrent vulvar Paget's disease

  5 years

Study Arms (1)

Trastuzumab

EXPERIMENTAL

Open Label

Drug: trastuzumab

Interventions

trastuzumab DRUG

monoclonal antibody

Trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas J. Rutherford, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 1, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

US (1)