A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

Status:	Completed
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	2 - Any
Updated:	4/5/2017
Start Date:	December 18, 2007
End Date:	February 19, 2014

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.

This study will evaluate the efficacy and safety of R1507 in participants with recurrent or
refractory sarcoma. Eight cohorts of sarcoma participants will be studied in parallel.
Cohort 1: Ewing's sarcoma primary cohort defined as participants who have relapsed less than
or equal to (<=) 24 months from diagnosis, received at least two prior chemotherapy programs
and are unresectable. Cohort 2: Ewing's sarcoma non-primary (secondary) cohort defined as
participants who have relapsed greater than or equal to (>=) 24 months from diagnosis or
have only received one prior chemotherapy program. Cohort 3: Expanded Ewing's sarcoma
defined as participants with recurrent or relapse regardless of prior number of salvage
regimens and regardless of time of relapse. Cohort 4: participants with osteosarcoma. Cohort
5: Participants with synovial sarcoma. Cohort 6: Participants with rhabdomyosarcoma Cohort
7: Participants with alveolar soft part sarcoma (7a), desmoplastic small round cell tumors
(7b), extraskeletal myxoid chondrosarcoma (7c), clear cell sarcoma (7d), myxoid liposarcoma
(7e). Cohort 8: Participants with unspecified sarcoma diagnosis. Participants in the
expanded Ewing's sarcoma Cohort 3 will receive 27 milligrams (mg)/kilogram (kg) every 3
weeks intravenously (IV). All other participants will receive R1507 9 mg/kg IV weekly. The
anticipated time on study treatment is until disease progression or unacceptable adverse
events, withdrawal or death.

Inclusion Criteria:

- 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:

- 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

We found this trial at

sites

University of Michigan Comprehensive Cancer Center

1500 East Medical Center Drive
Ann Arbor, Michigan 48109

800-865-1125