Cabozantinib + Temozolomide for Soft Tissue Sarcoma

Recruiting at 4 trial locations

Overseen By Mark Agulnik

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Anticoagulants, Platelet inhibitors

Disqualifiers: Pregnancy, Cardiac disease, GI disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

72 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well cabozantinib and temozolomide work in treating patients with leiomyosarcoma or other soft tissue sarcoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cabozantinib and temozolomide may work better than either one alone in treating patients with leiomyosarcoma or other soft tissue sarcoma. Cabozantinib is an investigational drug, which means that it has not been approved by the United States (US) Food and Drug Administration (FDA) or any other regulatory agencies for sale or use by the public for the indication under investigation in this study.

Research Team

Janet Yoon, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

My organ and bone marrow functions are within normal ranges.

I am using birth control or my partner is.

My brain cancer has not worsened after treatment.

Exclusion Criteria

I don't have another cancer that could affect this treatment's safety or results.

I have not had major surgery in the last 56 days.

I haven't had any radionuclide treatment in the last 42 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

28 days per cycle

Monthly visits for each cycle

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.

Up to 5 years

Biannual visits

Treatment Details

Interventions

• Cabozantinib
• Temozolomide

Trial Overview The study tests the combination of cabozantinib (an enzyme blocker) and temozolomide (a chemotherapy drug) on tumor growth in leiomyosarcoma or other soft tissue sarcomas. The goal is to see if this combo works better than either drug alone.

Participant Groups

Group I: Treatment (cabozantinib, temozolomide) Experimental Treatment 4 Interventions

Patients receive cabozantinib PO QD on days 1-28 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Cabometyx for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in United States as Cabometyx for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in Canada as Cabometyx for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in Japan as Cabometyx for:

• Renal cell carcinoma

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+