Thalidomide in Treating Patients With Gynecologic Sarcomas

June 20, 2013 updated by: New York University Cancer Institute

Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin

RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.
  • Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.
  • Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.

OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Cancer Center of Albany Medical Center
      • Bronx, New York, United States, 10461
        • Albert Einstein Clinical Cancer Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center
      • New York, New York, United States, 10019
        • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed sarcoma or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin not amenable to resection or radiotherapy

  • Measurable disease

    • Lesions accurately measured in at least 1 dimension of at least 20 mm in longest diameter with conventional techniques or at least 10 mm with helical CT scan
    • Histologically or cytologically confirmed neoplastic nature if solitary lesion

    • No nonmeasurable disease, defined as:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Unconfirmed abdominal masses not followed by imaging techniques
      • Cystic lesions
  • Documented recurrence or persistence following appropriate surgery, radiotherapy, and/or chemotherapy
  • Postmenopausal or status post hysterectomy

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 50,000/mm^3

Hepatic:

  • Bilirubin normal
  • Transaminases less than 2.5 times upper limit of normal

Renal:

  • Creatinine less than 1.5 mg/dL

Other:

  • No grade 2 or greater peripheral neuropathy
  • No medical or social factors that would preclude study, including inability to take oral medication
  • No other serious illness requiring immediate therapy
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • At least 30 days since any prior noncytotoxic experimental antiemetic or antifungal investigational drug

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

Collaborators and Investigators

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

Sponsor

New York University Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Scott Wadler, MD, Weill Medical College of Cornell University

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

September 1, 2000

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

August 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068013
  • NYGOG-99-001
  • NCI-314
  • NYOG-0102-073

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.

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