NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-C-0062

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 2 Years
Max Age: 30 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Small Molecule Inhibitor;
Kinase;
Rare Tumors;
Pediatric;
Solid Tumors

Recruitment Keyword(s)

None

Condition(s)

Ewing Sarcoma;
Rhabdomyosarcoma;
Wilms Tumor;
Medullary Thyroid Carcinoma;
Renal Cell Carcinoma

Investigational Drug(s)

XL184 (Cabozantinib)

Investigational Device(s)

None

Intervention(s)

Drug: Cabozantinib

Supporting Site

National Cancer Institute

Background:

The drug cabozantinib is also called XL184. It can reduce the growth of tumors and tumor blood vessels. Researchers want to find the most suitable dose that can be given safely to people with certain rare tumors that did not respond to or cannot be treated with standard therapy.

Objectives:

To study how XL184 affects certain rare tumors or cancers. To learn about its side effects and how it fights cancer and other immune cells.

Eligibility:

People ages 2-30 with certain rare tumors that did not respond to or cannot be treated with standard therapy

Design:

Participants will be screened by a review of their medical records.

The study will be done in 28-day cycles.

Participants will take XL184 by mouth once a day.

Participants will keep a diary of when they take the drug. They will also note the dose, side effects, and other drugs they take.

After every few cycles, participants will have tests, including:

-Blood and urine tests

-X-rays and scans

-Heart and lung tests

Participants ages 2-19 may have blood drawn 7 times during cycle 1 to see how their body processes the drug.

Participants may have blood drawn 3 times during cycles 1-3 to see how the drug affects their immune system.

Participants may have a tumor sample from a previous surgery sent to a lab.

Participants will continue therapy until they have serious side effects or their tumor worsens. After stopping therapy, participants will have follow-up tests at 30 days, then 1-2 times a year for 6 years.

--Back to Top--

Eligibility

ELIGIBILTY:

Greater than or equal to 2 years and < 30 years of age

Upper age limit of less than or equal to 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC)

Patients must have a body surface area greater than or equal to 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

--Adrenocortical 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

Adequate renal and liver function


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Brigitte C. Widemann, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3752
10 CENTER DR
BETHESDA MD 20892
(240) 760-6203
widemanb@mail.nih.gov

Brigitte C. Widemann, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3752
10 CENTER DR
BETHESDA MD 20892
(240) 760-6203
widemanb@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT02867592

--Back to Top--