CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Dinutuximab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02484443
NCT02484443Phase 2Completed

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

National Cancer Institute (NCI)·interventional·Posted Jun 29, 2015·Updated Oct 26, 2023

In Brief

A Phase 2 clinical trial evaluating Dinutuximab, Laboratory Biomarker Analysis, and 2 other interventions for Metastatic Malignant Neoplasm in the Lung and 2 related conditions. Completed, enrolled 41 participants across 130 sites in 5 countries.

Detailed Summary

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). Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them. Sargramostim may help the body increase the amount of white blood cells it produces, which help the body fight off infections. Giving dinutuximab with sargramostim may work better and kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 29, 2015
Enrollment StartFeb 4, 2016
Primary CompletionMar 31, 2020
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.0 years ago

Interventions

Dinutuximabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Sargramostimbiological

Given SC