Clinical trial · Observational
Blood and Tissue Study of Patients in NIH Protocol 08-C-0800
A Group Wide Biology and Banking Study for Phase II Study of R1507
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcomas | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Analyze tumor tissue for markers related to the mechanism of action of R1507
- timeFrame
- 6 months
- measure
- Determine if assays will allow for better identification
- timeFrame
- 6 months
- measure
- Determine whether serum levels of IGF are indicitive of patientoutcome
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- To determine whether specific tissue-based assays performed on diagnostic specimens will allow for the identification of newer prognostic categories and potentially new molecular targets for treatment of patients with sarcoma and other solid tum...
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* INCLUSION CRITERIA: All patients enrolled on the Phase II study SARC011/N021157 will be eligible for enrollment. Signed informed consent for this study according to institutional guidelines is required. EXCLUSION CRITERIA: None.
References
Publications (3)
- BACKGROUNDBonath K. [The halothane inhalation anesthesia in birds and its clinical control]. Berl Munch Tierarztl Wochenschr. 1975 Aug 1;88(15):299-301. No abstract available. German. PMID 1167146
- BACKGROUNDMyhre HO. Surgical treatment of aorto-iliac atherosclerosis. Acta Chir Scand. 1977;143(1):15-20. PMID 857553
- BACKGROUNDRosen N, Yee D, Lippman ME, Paik S, Cullen KJ. Insulin-like growth factors in human breast cancer. Breast Cancer Res Treat. 1991 May;18 Suppl 1:S55-62. doi: 10.1007/BF02633529. PMID 1651793