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	Treatment or Intervention	Phase
recurrent uterine sarcoma uterine leiomyosarcoma	Drug: thalidomide  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy	Phase II

Further Study 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.

Genders Eligible for Study:  Both

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

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States
California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States
      Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
Illinois
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612-3864,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
Iowa
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States
Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
New York
      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11794-8091,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Barrett Cancer Center, Cincinnati,  Ohio,  45267-0526,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
Tennessee
      Brookview Research, Inc., Nashville,  Tennessee,  37203,  United States
Texas
      CCOP - M.D. Anderson Research Base, Houston,  Texas,  77030-4009,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States
Vermont
      Fletcher Allen Health Care - Medical Center Campus, Burlington,  Vermont,  05401,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States
Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6188,  United States
Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway
United Kingdom, England
      University of Birmingham, Birmingham,  England,  B15 2TT,  United Kingdom

Study chairs or principal investigators

Scott McMeekin, MD,  Study Chair,  University of Oklahoma Health Sciences Center   

Study ID Numbers:  CDR0000068939; GOG-0231-B
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025220
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08