NCT00831844|CompletedPhase 2ResultsDMC

Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

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)ClinicalTrials.gov

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5 other identifiers

NCI-2009-01170CDR0000633186COG-ADVL0821ADVL0821U10CA098543

Study Type

interventional

Target

116

Locations

3 countries

Sites

105

Timeline

RegisteredJan 2009

StartedJan 2009

CompletionOct 2013

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

116

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach

3 countries

105 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.8 years study duration

Study Start

First participant enrolled

January 1, 2009

Completed

27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

March 30, 2015

Completed

Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

4.2 years

First QC Date

January 28, 2009

Results QC Date

March 18, 2015

Last Update Submit

March 18, 2015

Conditions

Adult 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

Outcome Measures

Primary Outcomes (1)

Disease Response
Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).
First six treatment cycles - 24 weeks

Study Arms (10)

Group 1 - Recurrent or Refractory Hepatoblastoma

EXPERIMENTAL

Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.