Cabozantinib + Temozolomide for Soft Tissue Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two drugs, cabozantinib and temozolomide, to evaluate their combined effectiveness against soft tissue sarcoma that cannot be surgically removed or has metastasized. Cabozantinib blocks tumor growth by inhibiting certain enzymes, while temozolomide is a chemotherapy drug that kills cancer cells or prevents their spread. The combination may prove more effective than using each drug alone. Candidates for this trial include those with soft tissue sarcoma who have undergone up to five different chemotherapy treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from potentially effective therapies.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications, but it does mention a washout period for certain treatments. If you are on oral anticoagulants or platelet inhibitors, you may need to stop them for a period before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of cabozantinib and temozolomide is under study for safety in treating certain types of soft tissue cancer, such as leiomyosarcoma. In earlier studies, researchers tested these drugs in patients with tumors that couldn't be surgically removed or had metastasized.
Temozolomide, a chemotherapy drug, has shown some effectiveness against various soft tissue cancers. Cabozantinib is still under investigation for this use and has not yet received FDA approval for treating these specific conditions.
While detailed safety information remains limited, the current trial phase indicates that researchers are assessing how well patients tolerate these treatments. The combination has passed earlier study stages, suggesting it was safe enough to continue testing.
Prospective participants should consult their doctor to understand the potential risks and benefits based on their specific health needs.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of cabozantinib and temozolomide for treating soft tissue sarcoma because it offers a unique approach compared to traditional therapies. Unlike standard treatments that often focus on surgery and radiation, cabozantinib works as a tyrosine kinase inhibitor, targeting specific proteins involved in tumor growth and spread. When paired with temozolomide, a chemotherapy agent that damages cancer cell DNA, this combination has the potential to more effectively inhibit tumor progression. This dual-action strategy could lead to better outcomes for patients who haven't responded well to conventional treatments.
What evidence suggests that cabozantinib and temozolomide might be an effective treatment for soft tissue sarcoma?
Research has shown that the combination of cabozantinib and temozolomide, which participants in this trial will receive, may help treat soft tissue sarcoma, including leiomyosarcoma, that cannot be surgically removed or has spread. Studies have found that this combination exceeded expectations in patients. Specifically, one study revealed that 37% of patients experienced tumor shrinkage or disappearance, indicating the treatment's effectiveness against the cancer. Animal studies, such as those involving mice, also demonstrated that these drugs work well together to halt tumor growth. These findings suggest that cabozantinib and temozolomide could be promising options for treating this type of cancer.12356
Who Is on the Research Team?
Janet Yoon, MD
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with leiomyosarcoma or other soft tissue sarcomas that can't be surgically removed or have spread. Participants must have a certain level of white blood cells, no more than five prior chemo treatments, controlled brain metastases, and good organ function. They should not be pregnant and must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cabozantinib orally once daily on days 1-28 and temozolomide orally once daily on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Patients with progressive disease are followed up every 6 months for up to 2 years, and patients without progressive disease are followed up every 6 months for up to 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Cabozantinib
- Temozolomide
Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator