Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed… (NCT02867592) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
United States109 participantsStarted 2017-05-18
Plain-language summary
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.
Who can participate
Age range
2 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Upper age limit of =\< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) =\< 30 years for all other diagnoses
* Patients must have a body surface area \>= 0.35 m\^2
* Patients must have recurrent or refractory disease, or newly diagnosed disease with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life; patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse:
* Ewing sarcoma
* Rhabdomyosarcoma (RMS)
* Non-rhabdomyosarcoma soft tissue sarcomas (STS) including microphthalmia transcription factor associated STS (alveolar soft part sarcoma \[ASPS\] and clear cell sarcoma \[CCS\])
* Osteosarcoma
* Wilms tumor
* Rare tumors
* Medullary thyroid carcinoma (MTC)
* Renal cell carcinoma (RCC)
* Hepatocellular carcinoma (HCC)
* Hepatoblastoma
* Adrenal coertex carcinoma
* Pediatric solid tumors (including central nervous system \[CNS\] tumors) with known molecular alterations in the targets of XL184 (i.e., MET amplification, overexpression, activating mutation, MET translocation, MET exon skipping mutations, activating RET mutations, RET rearrangement, overexpression or activation of AXL); documentation of the alteration from a Clinical Laboratory Improvement Act (CLIA) certified laboratory will be required
* Note: Documentation of any known tu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since my tumor type falls into one of the strata this trial is studying, can you tell me whether my specific diagnosis fits the osteosarcoma group or one of the other tumor groups, and how that affects what the trial is actually trying to find out?
2This is a Phase 2 trial that's no longer enrolling new patients — does that mean any results or safety data are available yet, and if so, what have they shown for a tumor like mine?
3Cabozantinib targets specific pathways involved in tumor growth; given my child's particular tumor type and any molecular or genetic features we know about, does it make biological sense that this drug might work for us?
4Because this trial involves a daily oral medication that can have side effects like high blood pressure, wound healing problems, and liver changes, how would we monitor for those, and how might that fit into our current treatment schedule and daily life?
5Before considering this trial, are there standard treatments or other clinical trials we should try first, or does my child's recurrent or refractory status mean this could be a reasonable next step to discuss?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.