A Phase II Study of Ipilimumab in Children and Adolescents with Stage III/IV Inoperable Melanoma

Protocol
13-043
Full Title
A Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 years) with Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma
Phase
II
Disease Status
Newly Diagnosed & Relapsed/Refractory
Purpose

Ipilimumab is a drug approved for the treatment of melanoma skin cancers in adults. It has been evaluated in children with cancer, but its use in children and adolescents is considered investigational. The purpose of this study is to evaluate the safety and effectiveness of ipilimumab in children and adolescents (ages 12 to less than 17) with inoperable stage III or stage IV melanoma. Participants will receive a dose that is higher than the FDA-approved dose, but has been shown in prior studies to be safe in children with cancer.

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 have inoperable stage III or stage IV melanoma of the skin (non-ocular).
  • This study is open to patients who are at least age 12 and less than 18.
  • Any number of prior therapies is permitted, but at least 4 weeks must have passed since completion of prior therapy and entry into the study.

For more information and to inquire about eligibility for this study, please contact Dr. Ira Dunkel at 212-639-2153.

Disease(s)
Melanoma
Locations
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