Clinical trial · Interventional
Thalidomide in Treating Patients With Gynecologic Sarcomas
Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin
NCT00006005CI-TRIAL-00010934completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| thalidomide | Drug | Thalidomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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 drugReferences
Publications (0)
Data not yet available
No reference posted for this study.