Research

Solid Tumor Treatment with Cixutumumab – Phase II

IMC-A12 in Treating Patients With Relapsed or Refractory Solid Tumors

Protocol Description

This Phase II Children’s Oncology Group trial is studying the side effects and how well the drug IMC-A12, also known as 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 Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, up to 30 years of age, who have been diagnosed with a malignant solid tumor that cannot be cured by any known standard treatment.
Males: Up to 30 years
Females: Up to 30 years

Requirements
Treatment consists of up to 24, 28-day cycles in which participants receive weekly doses of cixutumumab intravenously. Blood tests, electrocardiograms, urine tests and imaging studies will also be done. There will be up to four groups of participants, with dose levels increased successively for each of the last three groups.
Frequency of visits: Weekly for therapy and tests
Duration: Up to 96 weeks

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ADVL0821)
National Cancer Institute

Status: Open for Enrollment

Sources of Support
Children’s Oncology Group
National Cancer Institute

Additional Resources
Study Description at National Institutes of Health