Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresecta… (NCT00033709) | Clinical Trial Compass
UnknownPhase 2
Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
United StatesStarted 2002-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…