Thalidomide in Treating Patients With Gynecologic Sarcomas

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Thalidomide

Criteria

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