Phase II Study of Pegylated Interferon for Treating High-Risk Melanoma in Children

Program Overview

The main aim of this study is to find out how well the combination of peginterferon alfa-2b and temozolomide works in shrinking tumors in children with advanced melanoma. The study involves two groups based on the stage of the disease. Children with earlier stages of melanoma that have been surgically removed will receive peginterferon after an initial high dose of interferon. Those with more advanced or recurrent melanoma will receive both peginterferon and temozolomide.

Description

This study is for children with high-risk melanoma, which means the cancer is likely to return or spread, or has already come back. There are two treatment groups:

• Group A: For children with stage IIC, IIIA, or IIIB melanoma that has been removed by surgery. They will first receive high doses of interferon alfa-2b for 4 weeks, followed by peginterferon for 48 weeks.

• Group B: For children with stage IIIC or IV melanoma, melanoma that cannot be removed by surgery, or recurrent melanoma. This group is further divided into two subgroups based on whether the cancer can be measured. They will receive peginterferon and temozolomide for 8 weeks, with a 2-week break, and continue for several courses.

All children will have surgery to remove the melanoma if possible, with specific guidelines for how much tissue around the tumor should be removed. If cancer is found in the lymph nodes, those nodes will also be removed.

The study also aims to ensure the safety of these treatments and to see if the treatment plan is feasible for children with different stages of melanoma.

Eligibility Criteria

Locations