Study on Cabozantinib-S-Malate for Treating Young Patients with Sarcomas, Wilms Tumor, or Other Rare Tumors
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02867592
This clinical trial is testing how well the drug cabozantinib-s-malate works in young patients with certain types of tumors that have come back, don't respond to treatment, or are newly diagnosed. The drug may help stop tumor growth by blocking enzymes needed for tumor and blood vessel growth.
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Program Overview
This study is exploring the effectiveness of cabozantinib-s-malate in treating young patients with sarcomas, Wilms tumor, or other rare tumors that have returned, are resistant to treatment, or are newly diagnosed. The drug works by blocking certain enzymes that help tumors and their blood vessels grow.
Description
The main goals of this study are to see how well cabozantinib-s-malate works in children and young adults with specific types of tumors, such as Ewing sarcoma, rhabdomyosarcoma, and Wilms tumor. Researchers want to know if the drug can improve disease control in patients with osteosarcoma compared to past experiences. They also aim to understand the drug's side effects and how it behaves in the body.
Patients will take cabozantinib-s-malate by mouth every day in 28-day cycles, as long as the disease does not progress or cause unacceptable side effects. After finishing the treatment, patients will have follow-up visits at 30 days, every 6 months for a year, and then annually for up to 5 years.
Eligibility Criteria
Inclusion Criteria
- Patients must be 18 years or younger for certain cancers and up to 30 years for others.
- Must have a body surface area of at least 0.35 m².
- Must have recurrent, resistant, or newly diagnosed disease with no known curative therapy.
- Must have a confirmed diagnosis of specific tumors like Ewing sarcoma, rhabdomyosarcoma, or Wilms tumor.
- Must have measurable disease on scans.
- Must have a performance status score of 50 or higher, indicating they can perform daily activities.
- Must have recovered from previous treatments and meet specific blood count and organ function criteria.
- Must not have received certain treatments recently, such as myelosuppressive chemotherapy or radiation.
- Must not have received cabozantinib or similar drugs before.
- Must have adequate kidney, liver, and heart function.
Exclusion Criteria
- Pregnant or breastfeeding women cannot participate.
- Must not have received certain growth factors or medications recently.
- Must not be taking other investigational drugs or anti-cancer agents.
- Must not have uncontrolled infections or active bleeding.
- Must not have had recent major surgery or significant injuries.
- Must not have conditions that interfere with drug absorption.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Kaiser Permanente-Bellflower | 90706 | Bellflower | California |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| Kaiser Permanente-Fontana | 92335 | Fontana | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Kaiser Permanente Los Angeles Medical Center | 90027 | Los Angeles | California |
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