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Thalidomide in Treating Patients With Gynecologic Sarcomas

Primary Purpose

Endometrial Cancer, Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
thalidomide
Sponsored by
New York University Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Center of Albany Medical Center
  • Albert Einstein Clinical Cancer Center
  • North Shore University Hospital
  • St. Vincent's Comprehensive Cancer Center
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
  • New York Weill Cornell Cancer Center at Cornell University
  • Mount Sinai School of Medicine
  • New York Medical College
  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
June 20, 2013
Sponsor
New York University Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006005
Brief Title
Thalidomide in Treating Patients With Gynecologic Sarcomas
Official Title
Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
New York University Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Sarcoma
Keywords
stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
thalidomide

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Wadler, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Center of Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

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Thalidomide in Treating Patients With Gynecologic Sarcomas

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