A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

Trial ID or NCT#

NCT00615680

Status

not recruiting iconNOT RECRUITING

Purpose

The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.

Official Title

A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Participants With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.

Eligibility Criteria

Ages Eligible for Study: Older than 2 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma;* Cohort 3 only: age must be \>= 2 and \<= 21 years
Exclusion Criteria:
  1. * clinically significant unrelated systemic illness which would compromise the participant's ability to tolerate the investigational agent, or interfere with the study procedures or results;* known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies;* treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or other immunosuppressive agents;* current or prior therapy with insulin-like growth factor (IGF) inhibitor (monoclonal or specific kinase inhibitor);* history of solid organ transplant;* other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer;* active central nervous system disease
View All Criteria
Show Less

Investigator(s)

Neyssa Marina

Contact us to find out if this trial is right for you.

Contact

Maria Ahern
6507256413

View on ClinicalTrials.gov