Blood and Tissue Study of Patients in NIH Protocol 08-C-0800

December 13, 2019 updated by: National Cancer Institute (NCI)

A Group Wide Biology and Banking Study for Phase II Study of R1507

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

  • R1507 is a recombinant, fully human monoclonal IgG1 antibody that binds specifically to the human IGF-1R, resulting in direct inhibition of ligand binding and loss of receptor protein on the cell surface following intracellular internalization and degradation.
  • Binding of R1507 has been shown to inhibit signal transduction and proliferation and survival functions mediated by the IGF-1R in cancer cells. Pre-clinical toxicology and safety pharmacology studies have been performed with R1507 and phase 1 studies in adults have resulted in a recommended intravenous dose of 9 mg/kg weekly. Phase 1 studies are ongoing in children.
  • A Phase II study (SARC011/Roche NO21157): 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 will allow an opportunity to collect tumor tissue and serum samples to further characterize the biology of sarcomas and their response to IGF1-R monoclonal antibody therapy.

Objectives:

  • To analyze tumor tissue for IGF-1R, phosphor (p)-IGF-1R, Akt, p-Akt, PTEN, and other candidate markers related to the mechanism of action of R1507 in the treatment of patients with sarcoma and other solid tumors.
  • 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 tumors.
  • To determine whether serum levels of free IGF-I/II, total IGF-I and shed IGF-1R are of significance in the outcome of patients with sarcoma and other solid tumors.
  • To identify new treatment targets for therapy. Further testing of these potential targets will be carried out in hopes of expediting translation of these findings to the clinical setting.

Eligibility:

-All patients enrolled on the Phase II study SARC011/Roche NO21157 will be eligible for enrollment.

Design:

  • Unstained tumor tissue slides from samples sent for confirmatory diagnosis will be forwarded for further analysis from Central Pathology Labs in New York or Leiden to Roche Clinical Sample Operations (CSO). Tissue based assays to evaluate the status of IGF-1R downstream pathway will be performed by Roche Central Lab (HistoGeneX) and NCI Lab.
  • Serum based assays of free serum IGF-I/II, total serum IGF-I and shed IGF-1R receptor will be run using the samples obtained prior to the first dose of R1507 and at specified times during treatment as described in Table 3.3. All serum samples will be shipped to the Roche CSO and forwarded for analysis to the designated laboratories. Serum based assays will be performed by Roche Central Lab (MicroCoat) and Roche Diagnostics (Penzberg).

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analyze tumor tissue for markers related to the mechanism of action of R1507
Time Frame: 6 months
6 months
Determine if assays will allow for better identification
Time Frame: 6 months
6 months
Determine whether serum levels of IGF are indicitive of patientoutcome
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome 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...

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lee J Helman, M.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 9, 2008

Study Completion

May 18, 2017

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

May 18, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090054
  • 09-C-0054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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