Phase I Study of Ipilimumab (Anti-CTLA-4) in Children and Adolescents With Treatment-Resistant Cancer
Status:
Completed
Trial end date:
2015-11-13
Target enrollment:
Participant gender:
Summary
This study will examine the safety and efficacy of ipilimumab-an experimental cancer
treatment drug used to boost immune response-in children, adolescents, and young adults.
Ipilimumab may allow immune cells to react to and destroy abnormal cells in the body, and has
been tested in adults for a variety of cancers and has shown responses in some research
studies. Because ipilimumab has not been tested in children, adolescents, or young adults, it
is considered an experimental drug. The purposes of this research study are to determine the
highest safe dose of ipilimumab for children, adolescents, and young adults with solid tumor
cancers; examine its effectiveness and possible side effects; and better understand how the
body and the immune system process it over time.
Candidates must be between 2 and 21 years of age and must have solid malignant tumors that
have been resistant to standard therapy. Volunteers will be screened with a medical history,
a clinical examination, and computerized scans such as magnetic resonance imaging (MRI).
Participants must have completed their last dose of chemotherapy, radiation, chemotherapy, or
antibody or investigational therapy at least four weeks prior to enrollment.
During the study, participants will receive an intravenous dose of ipilimumab once every
three weeks. The infusion of ipilimumab will last 90 minutes, and the participant s vital
signs will be monitored while the medicine is infusing and several times in the first 24
hours after the first dose (requiring a hospital stay during that time). If the participant
is able to tolerate the first dose of ipilimumab, further doses (called cycles ) may be
received on an outpatient basis. Blood and urine tests will be given on a regular basis
during these cycles. After four cycles, participants whose tumors do not grow and who do not
have unacceptable side effects will continue to receive ipilimumab every three months to
maintain the current condition, until researchers conclude the study.