CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Cixutumumab +2 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/NCT01614795
NCT01614795Phase 2Completed
CompareCT.gov

A Phase II Study of Cixutumumab (IMC-A12) in Combination With Temsirolimus in Pediatric Patients With Recurrent or Refractory Solid Tumors

National Cancer Institute (NCI)·interventional·Posted Jun 8, 2012·Updated Dec 11, 2018

In Brief

A Phase 2 clinical trial evaluating Cixutumumab, Laboratory Biomarker Analysis, and 1 other intervention for Childhood Alveolar Soft Part Sarcoma and 14 related conditions. Completed, enrolled 46 participants across 76 sites in 2 countries.

Detailed Summary

This phase II trial studies how well cixutumumab and temsirolimus work in treating patients with recurrent or refractory sarcoma. 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. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Alveolar Soft Part Sarcoma, Childhood Angiosarcoma, Childhood Epithelioid Sarcoma, Childhood Fibrosarcoma, Childhood Gliosarcoma, Childhood Leiomyosarcoma, Childhood Liposarcoma, Childhood Malignant Peripheral Nerve Sheath Tumor, Childhood Synovial Sarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Osteosarcoma, Rhabdomyosarcoma
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2012
Enrollment StartJun 18, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.1 years ago

Interventions

Cixutumumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Temsirolimusdrug

Given IV