Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic, locally advanced, or unresectable leiomyosarcoma.

Detailed Description
-----------------
OBJECTIVES: Determine the efficacy of temozolomide and thalidomide in patients with metastatic, locally advanced, or unresectable leiomyosarcoma. Determine the time to progression in patients treated with this regimen. Determine the overall survival of patients treated with this regimen. Determine the clinical and laboratory toxic effects and tolerability of this regimen in these patients. OUTLINE: Patients receive oral temozolomide once daily for 7 days every other week and oral thalidomide once daily. Treatment continues for up to 26 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 7.5-25 months.

Official Title
-----------------
A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic, Locally Advanced or Unresectable Leiomyosarcoma

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Drug: temozolomide
* Drug: thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed leiomyosarcoma Metastatic, locally advanced, or unresectable Ineligible for other high priority national or institutional study At least 1 unidimensionally measurable lesion documented on radiologic study At least 2 cm by 2 cm Not previously irradiated unless disease progression at the site is evident No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: More than 2 months Hematopoietic: WBC greater than 3,000/mm^3 Neutrophil count at least 1,500/mm^3 Platelet count greater than 70,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than upper limit of normal (ULN) SGOT or SGPT less than 1.5 times ULN* Alkaline phosphatase less than 2 times ULN* NOTE: * Less than 5 times ULN if documented liver disease Renal: Creatinine less than 1.5 times normal OR Creatinine clearance greater than 60 mL/min BUN less than 1.5 times normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study therapy No acute infection requiring systemic antibiotics No frequent vomiting or medical condition that would preclude intake of oral medication (e.g., partial bowel obstruction) No other serious medical or psychiatric illness that would preclude study participation No prior malignancy except curatively treated carcinoma in situ of the cervix or skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy No more than 3 prior systemic chemotherapy regimens for metastatic, locally advanced, or unresectable leiomyosarcoma Prior dacarbazine allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to 50% or more of bone marrow Concurrent radiotherapy for local control or palliative therapy for painful bony or soft tissue lesion allowed Surgery: At least 4 weeks since prior surgery and recovered Other: Recovered from all prior therapies No other concurrent investigational drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: temozolomide|nan|
|Drug: thalidomide|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response (complete and partial response) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Overall survival |  |  | 
| Clinical benefit |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult leiomyosarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine leiomyosarcoma, stage IV adult soft tissue sarcoma