This study is currently not recruiting participants.

A Phase 2 Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab NSC# 764038) in Combination With Sargramostim (GM-CSF) in Patients With Recurrent Osteosarcoma

Study of Investigational Medication with Sargramostim for Recurrent Osteosarcoma

Not Recruiting
29 years or below
All
Phase N/A
1 Location

Brief description of study.

This phase II trial studies how well dinutuximab works when given with sargramostim in treating patients with osteosarcoma that has come back after treatment (recurrent).

Detailed description of study

The purpose of this study is to determine the disease control rate in patients with completely resected recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim (granulocyte-macrophage colony-stimulating factor [GM-CSF]) as compared to historical Children's Oncology Group (COG) experience.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: osteosarcoma
  • Age: 29 years or below
  • Gender: All

This study investigates the effectiveness of an investigational medication combined with sargramostim in treating patients with osteosarcoma that has returned after initial treatment. Osteosarcoma is a type of bone cancer. The investigational medication, dinutuximab, is being studied to see how well it works when used with sargramostim, which is a substance that helps stimulate the growth of certain blood cells.

Participants in the study will receive treatment with the investigational medication along with sargramostim. The study aims to assess the disease control rate, which refers to the ability to keep the cancer from growing or spreading, in patients whose osteosarcoma has been completely surgically removed. The results will be compared to past experiences from the Children's Oncology Group.

  • Who can participate: The study is for patients with recurrent osteosarcoma that has been completely removed by surgery. Participants must have a history of osteosarcoma that has returned after previous treatment.
  • Study details: Participants will receive an investigational medication along with sargramostim. A placebo is not used in this study.
Updated on 19 Feb 2024. Study ID: 1512176359 (PHO-COG-FALLO

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the study team