CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
cixutumumab +1 morebiological
Likely dose
cixutumumab 9 mg/kgfrom 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/NCT00831844
NCT00831844Phase 2Completed
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A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, NSC #742460) in Children With Relapsed/Refractory Solid Tumors

National Cancer Institute (NCI)·interventional·Posted Jan 29, 2009·Updated Mar 30, 2015

In Brief

A Phase 2 clinical trial evaluating cixutumumab and laboratory biomarker analysis for Adult Rhabdomyosarcoma and 15 related conditions. Completed, enrolled 116 participants across 105 sites in 3 countries.

Detailed Summary

This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Rhabdomyosarcoma, Adult Synovial Sarcoma, Childhood Hepatoblastoma, Childhood Synovial Sarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adrenocortical Carcinoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Liver Cancer, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive, Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Recurrent Retinoblastoma, Recurrent Wilms Tumor and Other Childhood Kidney Tumors
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2009
Enrollment StartJan 1, 2009
Primary CompletionApr 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.4 years ago

Interventions

cixutumumabbiological

Given IV: Week 1 day 1, 9 mg/kg/dose over 1 hour. Week 2 Day 8, 9 mg/kg/dose over 1 hour. Week 3 Day 15, 9 mg/kg/dose over 1 hour. Week 4 Day 22, 9 mg/kg/dose over 1 hour.

laboratory biomarker analysisother

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