Cabozantinib for Rare Cancers in Young Patients

Recruiting in Palo Alto (17 mi)

+151 other locations

Overseen bySrivandana Akshintala

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.

Research Team

Srivandana Akshintala

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for young patients up to 18 years old with specific rare tumors or sarcomas, including Wilms tumor, and some up to 30 years old. They must have measurable disease, adequate organ function, no prior treatment with MET/HGF inhibitors like XL184, and not be on certain medications that affect the liver or heart.

Inclusion Criteria

You have a rare cancer called Wilms tumor.

You must be between the ages of 18 and 30 years, depending on the type of cancer being studied.

You have a type of thyroid cancer called medullary thyroid carcinoma (MTC).

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Exclusion Criteria

Inability to comply with safety monitoring requirements

Invasive procedures within specified timeframes

Significant traumatic injury within 28 days prior to enrollment

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Treatment Details

Interventions

Cabozantinib-S-malate (Tyrosine Kinase Inhibitor)

Trial OverviewThe effectiveness of Cabozantinib-S-Malate is being tested in this phase II trial. It's aimed at treating children and young adults whose tumors are recurrent, resistant to therapy or newly diagnosed without known curative options.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (cabozantinib s-malate)Experimental Treatment3 Interventions

Patients receive cabozantinib-s-malate orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.