Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

June 21, 2013 updated by: Southwest Oncology Group

Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Trastuzumab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic synovial sarcoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the response rate (confirmed complete response and partial response) in patients with HER2/neu-overexpressing locally advanced or metastatic synovial sarcoma treated with trastuzumab (Herceptin^®).

Secondary

  • Determine the frequency and severity of toxic effects of this drug in these patients.
  • Determine overall survival and progression-free survival of patients treated with this drug.
  • Correlate, preliminarily, SYT-SSX translocation, HER2/neu expression, and monophasic and biphasic phenotype with clinical outcomes in patients treated with this drug.

OUTLINE: This is a pilot, multicenter study.

Patients receive trastuzumab (Herceptin^®) IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 weeks until disease progression and then every 6 months for up to 2 years from study entry.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-40 months.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed synovial sarcoma meeting 1 of the following stage criteria:

    • Locally advanced disease, defined as 1 of the following:

      • Incurable by conventional multidisciplinary therapy, including surgery
      • Surgically resectable only with significant morbidity
    • Metastatic disease
  • Tumor HER2/neu positive (2+ or 3+) by immunohistochemistry
  • Tumor tissue must be available AND patient must be willing to allow specimen submission
  • Measurable disease
  • No known CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,000/mm^3
  • Hemoglobin > 8 g/dL
  • Platelet count > 100,000/mm^3

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • SGOT and/or SGPT < 1.5 times ULN (5 times ULN if liver metastases are present)

Renal

  • Creatinine < 1.5 times ULN OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • LVEF > 45% by MUGA

Gastrointestinal

  • No active peptic ulcer disease
  • No active gastrointestinal bleeding
  • No active inflammatory bowel disease

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No known HIV positivity
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent filgrastim (G-CSF)

Chemotherapy

  • At least 3 weeks since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 60 days since prior radiotherapy to the target lesion*
  • No concurrent radiotherapy NOTE: *Lesion must have demonstrated disease progression after completion of therapy

Surgery

  • At least 21 days since prior major surgery and recovered

Other

  • At least 60 days since prior embolization or radiofrequency ablation to the target lesion* NOTE: *Lesion must have demonstrated disease progression after completion of therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate (confirmed complete response and partial response)

Secondary Outcome Measures

Outcome Measure
Toxicity
Progression-free survival at 1 and 2 years
Overall survival at 1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Ernest C. Borden, MD, The Cleveland Clinic
  • Rashmi Chugh, MD, University of Michigan Rogel Cancer Center
  • George D. Demetri, MD, Dana-Farber Cancer Institute
  • Margaret von Mehren, MD, Fox Chase Cancer Center
  • Vivien H.C. Bramwell, MB, BS, PhD, FRCP, Tom Baker Cancer Centre - Calgary
  • Karen H. Albritton, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000413703
  • SWOG-S0346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcoma

Clinical Trials on trastuzumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe