Study on Cabozantinib and Temozolomide for Treating Unremovable or Spread Leiomyosarcoma and Other Soft Tissue Sarcomas
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT04200443
This clinical trial is exploring how well the combination of cabozantinib and temozolomide works in treating patients with leiomyosarcoma or other soft tissue sarcomas that cannot be surgically removed or have spread to other parts of the body.
Patient Parameters
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Program Overview
This study is testing a combination of two drugs, cabozantinib and temozolomide, to see if they can better control leiomyosarcoma and other soft tissue sarcomas that cannot be removed by surgery or have spread. Cabozantinib is thought to stop tumor growth by blocking certain enzymes, while temozolomide is a chemotherapy drug that kills cancer cells or stops them from growing and spreading. The study aims to find out if using both drugs together is more effective than using them separately. Cabozantinib is still being studied and is not yet approved by the FDA for this specific use.
Description
The main goal of this study is to see how long patients can live without their cancer getting worse when treated with cabozantinib and temozolomide. Researchers will also look at how many patients' tumors shrink or stay the same size, how long patients live overall, and how safe and tolerable the treatment is. The study will also assess the quality of life of participants using specific questionnaires.
Participants will take cabozantinib by mouth every day and temozolomide by mouth for the first five days of each 28-day cycle. This will continue as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will be monitored every six months for up to five years to track their health and any changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of leiomyosarcoma or other soft tissue sarcoma that cannot be removed by surgery or has spread.
- Must not have certain types of sarcomas like alveolar soft-part sarcoma or Kaposi sarcoma.
- Must be in good general health with an ECOG performance status of 0 or 1.
- Can have had up to five previous chemotherapy treatments for their cancer.
- Must have measurable disease based on specific criteria.
- Must have adequate organ and bone marrow function as shown by specific blood tests.
- Must agree to use effective birth control during the study and for four months after the last dose.
- Women must not be pregnant and must have a negative pregnancy test before starting the study.
- Must have recovered from any side effects of previous treatments to a certain level.
- Must be able to understand and agree to the study requirements and sign a consent form.
Exclusion Criteria
- Cannot swallow tablets.
- Have allergies to the study drugs or similar medications.
- Have another cancer that could interfere with the study.
- Are pregnant or breastfeeding.
- Have previously been treated with cabozantinib or temozolomide.
- Have had certain treatments like other cancer drugs or radiation therapy too recently before starting the study.
- Have uncontrolled heart conditions or high blood pressure.
- Have gastrointestinal issues that could increase the risk of complications.
- Have significant bleeding issues or other serious health problems that could affect participation.
- Are taking certain blood thinners or other medications that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| Northwestern University | 60611 | Chicago | Illinois |
| University of Iowa/Holden Comprehensive Cancer Center | 52242 | Iowa City | Iowa |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Medical College of Wisconsin | 53226 | Milwaukee | Wisconsin |
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