|
Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus Clinical research trials and Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus. Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus clinical trial. Participants frequently get the best healthcare available for their Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus  Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus
For Condition: recurrent uterine sarcoma,uterine leiomyosarcoma
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine leiomyosarcoma. - Determine the nature and degree of the toxicity of this drug in these patients. - Determine the partial and complete response rates in patients treated with this drug. - Determine the duration of PFS and overall survival of patients treated with this drug. - Determine the effect of this drug on initial performance status in these patients. - Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors (vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine of these patients. - Assess the association of endogenous angiogenesis factors with clinical outcome (PFS) in patients treated with this drug. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary uterine leiomyosarcoma (LMS) that is refractory to curative therapy or established treatments - Recurrent or persistent disease - At least 1 unidimensionally measurable target lesion - At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR - At least 10 mm by spiral CT scan - Tumors within a previously irradiated field are considered non-target lesions - No smooth muscle tumor of uncertain malignant potential, including metastatic or recurrent disease from such a tumor - Must have received 1 prior initial chemotherapy regimen (including high-dose, consolidation, or extended therapy after surgical or nonsurgical assessment) for uterine LMS - Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active phase III protocol for the same patient population - No documented brain metastases since diagnosis of cancer - Patients with stable CNS deficits are allowed provided there are no brain metastases, as confirmed by CT scan or MRI PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-2 if received 1 prior therapy regimen - GOG 0-1 if received 2 prior therapy regimens Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance greater than 60 mL/min Other: - No documented seizure disorders since diagnosis of cancer - Patients with a history of seizure disorders are allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months)while on an appropriately monitored treatment regimen - No active infection requiring antibiotics - No greater than grade 1 sensory or motor neuropathy - No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer - Not pregnant - Negative pregnancy test - Fertile patients must use at least 1 highly active method and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior thalidomide - At least 3 weeks since prior immunologic agents for uterine LMS Chemotherapy: - See Disease Characteristics - At least 3 weeks since other prior chemotherapy for uterine LMS and recovered - No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine LMS - No prior non-cytotoxic chemotherapy for recurrent or persistent uterine LMS Endocrine therapy: - At least 1 week since prior hormonal therapy for uterine LMS - Concurrent hormone replacement therapy allowed Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy for uterine LMS and recovered - No prior radiotherapy to more than 25% of bone marrow Surgery: - See Disease Characteristics - Recovered from recent prior surgery Other: - No prior anticancer therapy that would preclude study therapy - At least 3 weeks since other prior therapy for uterine LMS
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottMcMeekin, Study Chair, University of Oklahoma Health Sciences Center
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6188
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Birmingham
Birmingham, England, B15 2TT
United Kingdom
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3864
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000068939; GOG-0231-B
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025220
Other Uterine Leiomyosarcoma Studies:
1. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus
2. Chemotherapy in Treating Patients With Sarcoma of the Uterus
3. Combination Chemotherapy and Filgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
4. Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus
5. Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Related Studies:
Other uterine leiomyosarcoma Clinical Trials
Other New York Clinical Trials
Other Brooklyn Clinical Trials
Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus
|
|
|
|
|
|
|
|
