Thalidomide in Treating Patients With Gynecologic Sarcomas
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Sarcoma |
Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin |
| Study Start Date: | September 2000 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Cancer Center of Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Albert Einstein Clinical Cancer Center | |
| Bronx, New York, United States, 10461 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| St. Luke's-Roosevelt Hospital Center - Roosevelt Division | |
| New York, New York, United States, 10019 | |
| St. Vincent's Comprehensive Cancer Center | |
| New York, New York, United States, 10011 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Study Chair: | Scott Wadler, MD | Weill Medical College of Cornell University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006005 History of Changes |
| Other Study ID Numbers: | CDR0000068013, NYGOG-99-001, NCI-314, NYOG-0102-073 |
| Study First Received: | July 5, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Adenoma Sarcoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Thalidomide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013