Blood and Tissue Study of Patients in NIH Protocol 08-C-0800
Completed
Conditions studied: Sarcomas
In brief
Background: * This study is a companion biology study to NIH protocol 08-C-0080, A Phase II Trial of R1507, a Recombinant Human Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Patients with Recurrent or Refractory Ewing s Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas. * Analysis of tumor tissue and blood samples from patients with sarcomas who are receiving treatment with the experimental drug R1507 may help elucidate the biology of sarcomas and how they respond to certain therapies with monoclonal antibodies. Objectives: * To study the effect over time of R1507 on the proteins and cells in the blood and tissue of patients with sarcoma in order to learn more about how patients respond to the treatment and what changes occur in their cells. * To discover possible new treatments for cancer. Eligibility: * Participants in NIH protocol 08-C-0080 for the study of R1507 to treat people with various sarcomas. Design: * Patients who previously agreed as part of protocol 08-C-0800 to have blood sampling for pharmacodynamic studies (blood draws to test blood for levels of R1507 and how the body affects R1507) will not have any additional blood drawn as part of this study. * Patients who did not previously agree to pharmacodynamic sampling as part of the protocol 08-C-0800 will be asked to give 6 blood samples at various time periods during the study. * Pathology slides or tissue blocks obtained under protocol 08-C-0800 will be forwarded to F. Hoffmann-La Roche laboratories for analysis.
Key facts
- Study ID
- NCT00923325
- Run by
- National Cancer Institute (NCI)
- People needed
- 8
- Starts
- 2008-12-09
- Expected to finish
- 2017-05-18
- Last updated by the study team
- 2019-12-16
Who can join
Age: 2 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- None.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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