This study is NOT currently recruiting participants.
Number
21-C-0021
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: No longer recruiting/follow-up only Gender: Male & Female Min Age: 6 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women
Keywords
EWS-FLI1 mutation; Osteosarcoma; Alovudine
Recruitment Keyword(s)
None
Condition(s)
Sarcoma, Ewing; Sarcoma
Investigational Drug(s)
18F-FLT Trabectedin
Investigational Device(s)
Intervention(s)
Drug: Trabectedin and Irinotecan
Supporting Site
National Cancer Institute
Ewing sarcoma (ES) is a malignant bone tumor of childhood. Overall survival for people with this disease is poor. New, more effective therapies are needed. Researchers want to see if a combination of drugs can help.
Objective:
To find the safest combination of trabectedin and irinotecan that can be given to people with ES.
Eligibility:
People ages 6 and older with relapsed and refractory Ewing sarcoma with EWS-FLI1 fusion type.
Design:
Participants will be screened with:
Medical record review
Physical exam
Assessment of their ability to complete daily activities
Tumor biopsy if a sample is not available
Blood tests
Heart function tests
Tumor imaging. They will receive a contrast dye.
Some blood and tumor samples may be used for genetic testing or future research.
Participants will have a catheter inserted into a large vein in the arm or under the collar bone. This may be done under local anesthesia. They will get the study drugs via infusion into the catheter. Treatment will be given in 21-day cycles, for up to 18 months. They will stop getting the drugs if they have bad side effects or if their disease gets worse.
Participants will have multiple study visits each cycle. At these visits, they will repeats some screening tests. They may also have Positron Emission Tomography scans using 18F-FLT, a radiolabeled tracer used to identify tumor cells.
In the first year after they stop taking the study drugs, participants will have 4 follow-up visits. Then they will have yearly visits for up to 5 years.
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Eligibility: Individuals >=6 years of age with diagnosis of relapsed and refractory Ewing sarcoma with EWS-FLI1 fusion type for which there is no known therapy proving to prolong survival.
Individuals >=6 years of age with diagnosis of relapsed and refractory Ewing sarcoma with EWS-FLI1 fusion type for which there is no known therapy proving to prolong survival.
Principal Investigator
Referral Contact
For more information: