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| ID | Type | Description | Link |
|---|---|---|---|
| NYGOG-99-001 | |||
| NCI-314 | |||
| NYOG-0102-073 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thalidomide | Drug |
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:
Documented recurrence or persistence following appropriate surgery, radiotherapy, and/or chemotherapy
Postmenopausal or status post hysterectomy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Wadler, MD | Weill Medical College of Cornell University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of Albany Medical Center | Albany | New York | 12208 | United States | ||
| North Shore University Hospital |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D012509 | Sarcoma |
| D018203 | Sarcoma, Endometrial Stromal |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Manhasset |
| New York |
| 11030 |
| United States |
| St. Vincent's Comprehensive Cancer Center | New York | New York | 10011 | United States |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York | 10016 | United States |
| St. Luke's-Roosevelt Hospital Center - Roosevelt Division | New York | New York | 10019 | United States |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Albert Einstein Clinical Cancer Center | The Bronx | New York | 10461 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D018193 | Neoplasms, Complex and Mixed |
| D036821 | Endometrial Stromal Tumors |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |