AOST1421: A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC# 764038, IND# 4308) in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma

Protocol: 
AAAQ6364
Phase: 
II

AOST1421: A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC# 764038, IND# 4308) in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma

This phase II trial studies how well dinutuximab works when given with
sargramostim in treating patients with recurrent osteosarcoma. Monoclonal
antibodies, such as dinutuximab, may find tumor cells and help kill them.
Sargramostim is being given to help improve the effect of dinutuximab. Patients
receive sargramostim on days 1-14 and dinutuximab IV over 20 hours on days 4 and
5. Treatment is repeated every 28 days for up to 5 courses if there is no
evidence of disease progression or unacceptable side effects.

Are you Eligible? (Inclusion Criteria)

-Subjects may be up to 29 years of age at the time of study entry.
-Patients must have histologic diagnosis of osteosarcoma at original diagnosis
-Patients must have had at least one episode of disease recurrence.
-Recurrence must be isolated to the lungs and has been completely removed
surgically
-Patients must also meet all eligibility criteria as outlined in the study
protocol.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States