NCT00923325

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2017

Completed
Last Updated

December 16, 2019

Status Verified

May 18, 2017

First QC Date

June 17, 2009

Last Update Submit

December 13, 2019

Conditions

Sarcomas

Keywords

Biomarker AnalysisSarcomasEwing's SarcomaOsteosarcomaRhabdomyosarcomaSynovial SarcomaOther Sarcoma

Outcome Measures

Primary Outcomes (3)

  • Analyze tumor tissue for markers related to the mechanism of action of R1507

    6 months

  • Determine if assays will allow for better identification

    6 months

  • Determine whether serum levels of IGF are indicitive of patientoutcome

    6 months

Secondary Outcomes (1)

  • 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 Criteria

Age2 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Bonath 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: 1167146BACKGROUND

  • Myhre HO. Surgical treatment of aorto-iliac atherosclerosis. Acta Chir Scand. 1977;143(1):15-20.

    PMID: 857553BACKGROUND

  • Rosen 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: 1651793BACKGROUND

MeSH Terms

Conditions

SarcomaSarcoma, EwingOsteosarcomaRhabdomyosarcomaSarcoma, Synovial

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone TissueNeoplasms, Connective TissueMyosarcomaNeoplasms, Muscle Tissue

Study Officials

  • Lee J Helman, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

December 9, 2008

Study Completion

May 18, 2017

Last Updated

December 16, 2019

Record last verified: 2017-05-18

Locations

US(1)