|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
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: | Masking: Open Label Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00025220 History of Changes |
| Other Study ID Numbers: | CDR0000068939, GOG-0231-B |
| Study First Received: | October 11, 2001 |
| Last Updated: | August 6, 2008 |
| Health Authority: | United States: Federal Government |
|
recurrent uterine sarcoma uterine leiomyosarcoma |
|
Leiomyosarcoma Uterine Neoplasms Sarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female 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 |