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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.