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NCT02484443 · ClinicalTrials.gov registry record · Phase 2
Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma
A Phase 2 study of Recurrent Osteosarcoma and Metastatic Malignant Neoplasm in the Lung, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 20
- Study locations
NCT02484443: Completed Phase 2 study of Recurrent Osteosarcoma and Metastatic Malignant Neoplasm in the Lung, sponsored by National Cancer Institute (NCI).
NCT02484443 is a Phase 2 study of Recurrent Osteosarcoma and Metastatic Malignant Neoplasm in the Lung that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 41 participants, below the 63-participant average among 13 other Recurrent Osteosarcoma trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02484443, a Phase 2 study of Recurrent Osteosarcoma and Metastatic Malignant Neoplasm in the Lung, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Patients who can be confirmed to be free of detectable disease 12 months after enrollment, without intervening disease progression, will be considered to have demonstrated 12 month disease control. All other eligible patients will be considered not to have demonstrated 12 month disease control.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Sargramostim
- OTHER Pharmacological Study
- BIOLOGICAL Dinutuximab
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- UCSF Medical Center-Mission Bay - San Francisco
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2016-02-04 |
| Est. Completion | 2023-09-30 |
| Phase | Phase 2 |
What the finished NCT02484443 record still lists
NCT02484443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 63-participant average among 13 other Recurrent Osteosarcoma trials with a reported enrollment target (35% lower).
The record links to 3 conditions, with Recurrent Osteosarcoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02484443 names 20 study sites across 9 states, led by California, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT02484443 about?
NCT02484443 is a clinical study titled "Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma". 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 ...
What is the current status of trial NCT02484443?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2016-02-04. Estimated completion is 2023-09-30.
What conditions does trial NCT02484443 study?
This clinical trial studies the following conditions: Recurrent Osteosarcoma, Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma.
What interventions are being tested in trial NCT02484443?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Sargramostim (BIOLOGICAL), Pharmacological Study (OTHER), Dinutuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02484443?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02484443 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Osteosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02484443's enrollment target sits among peer trials
41 7th of 13 higher than 7 of 13 other Recurrent Osteosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Osteosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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