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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025220 |
Purpose
RATIONALE: Thalidomide may stop the growth of cancer 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 cancer of the uterus.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Evalutaion of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus |
| Study Start Date: | September 2001 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks 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 22-60 patients will be accrued for this study within 7-21 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary uterine leiomyosarcoma (LMS) that is refractory to curative therapy or established treatments
At least 1 unidimensionally measurable target lesion
No documented brain metastases since diagnosis of cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 36 Study Locations| Study Chair: | D. Scott McMeekin, MD | Oklahoma University Cancer Institute |
More Information
| Study ID Numbers: | CDR0000068939, GOG-0231-B |
| Study First Received: | October 11, 2001 |
| Last Updated: | August 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00025220 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent uterine sarcoma uterine leiomyosarcoma |
|
Immunologic Factors Thalidomide Leiomyosarcoma Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Angiogenesis Inhibitors Immunosuppressive Agents Recurrence |
Genital Diseases, Female Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Malignant Mesenchymal Tumor Soft Tissue Sarcomas Uterine Sarcoma Sarcoma Uterine Neoplasms |
|
Anti-Infective Agents Neoplasms by Histologic Type Thalidomide Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Angiogenesis Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Genital Diseases, Female Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Site Therapeutic Uses Sarcoma Uterine Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |