Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Thalidomide in Treating Patients With Gynecologic Sarcomas

Summary: 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.

Detailed description: 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: 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

Relevance to patient case: not relevant