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NCT00082758 · ClinicalTrials.gov registry record · Phase 2
hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
A Phase 2 study of Neuroblastoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 20
- Study locations
NCT00082758: Completed Phase 2 study of Neuroblastoma, sponsored by Children's Oncology Group.
NCT00082758 is a Phase 2 study of Neuroblastoma that has completed, run by Children's Oncology Group. The registered enrollment target is 39 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00082758, a Phase 2 study of Neuroblastoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating young patients with recurrent or refractory neuroblastoma.
Primary Outcome
Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In
Conditions Studied
Interventions
- BIOLOGICAL hu14.18-Interleukin-2 fusion protein
Study Locations (20)
California
- Childrens Hospital Los Angeles - Los Angeles
- Children's Hospital Central California - Madera
- Children's Hospital of Orange County - Orange
- Sutter Cancer Center - Sacramento
- UCSF Comprehensive Cancer Center - San Francisco
- Stanford Comprehensive Cancer Center - Stanford - Stanford
Florida
- University of Florida Shands Cancer Center - Gainesville
- Sacred Heart Cancer Center at Sacred Heart Hospital - Pensacola
- St. Joseph's Cancer Institute at St. Joseph's Hospital - Tampa
- Kaplan Cancer Center at St. Mary's Medical Center - West Palm Beach
Illinois
- Children's Memorial Hospital - Chicago - Chicago
- University of Chicago Cancer Research Center - Chicago
- Southern Illinois University School of Medicine - Springfield
Alabama
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham - Birmingham
Arkansas
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences - Little Rock
Colorado
- Children's Hospital Cancer Center - Denver
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- MBCCOP - Medical College of Georgia Cancer Center - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2005-08 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT00082758 record still lists
NCT00082758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which hu14.18-Interleukin-2 fusion protein is the first listed.
NCT00082758 names 20 study sites across 10 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00082758 about?
NCT00082758 is a clinical study titled "hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma". RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating young patients with recurren...
What is the current status of trial NCT00082758?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2005-08. Estimated completion is 2012-05.
What conditions does trial NCT00082758 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT00082758?
The interventions under investigation include: hu14.18-Interleukin-2 fusion protein (BIOLOGICAL).
Who is sponsoring clinical trial NCT00082758?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00082758 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
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 NCT00082758's enrollment target sits among peer trials
39 54th of 94 higher than 40 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma 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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