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Protocol Details

SARC037: A Phase I Study to Evaluate the Safety of Trabectedin Administered as a 1-Hour Infusion in Ewing Sarcoma Patients in Combination with Low Dose Irinotecan and 3'Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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)

None

Intervention(s)

Drug: Trabectedin and Irinotecan

Supporting Site

National Cancer Institute

Background:

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

Eligibility:

Individuals >=6 years of age with diagnosis of relapsed and refractory Ewing sarcoma with EWSFLI1 fusion type for which there is no known therapy proving to prolong survival.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

John W. Glod, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6194
john.glod@nih.gov

Elaine W. Thomas
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 1C244
10 Center Drive
Bethesda, Maryland 20892
(240) 858-7013
elaine.thomas@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:

NCT04067115

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