A Phase I Study of Ipilimumab in Children, Adolescents, and Young Adults with Treatment-Refractory Cancer

Protocol
10-193
Full Title
A Phase 1 Study of Ipilimumab (Anti-CTLA-4) in Children, Adolescents and Young Adults with Treatment Refractory Cancer (NCI Protocol # 7458)
Purpose

The purpose of this study is to find the highest dose of the drug ipilimumab that can be given safely to children, teenagers, and young adults with solid tumors that persist despite standard therapy or for which no standard therapy exists. Researchers will see how the cancer responds to this drug, how the body handles ipilimumab, and how the immune system responds to this treatment. Ipilimumab is approved for treating advanced melanoma, but its use in this study is considered investigational.

Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through this shut-down mechanism. An antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune reaction to continue. This immune reaction may help the body to destroy cancer cells.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be between the ages of 2 and 21 (inclusive).
  • Patients must have a solid tumor that has persisted or returned despite prior therapy and for which no other standard therapies exist.
  • At least 4 weeks must have passed since completion of prior treatment and entry into the study, and patients must have recovered from any serious side effects.

For more information about this study and to inquire about eligibility, please contact Dr. Leonard H. Wexler at 212-639-7990.

Disease(s)
Lymphoma
Lymphoma: Hodgkin's Disease
Lymphoma: Non-Hodgkin's Lymphoma
Melanoma
Sarcomas
Locations
Related Diseases