Protocol

MEL06: Phase II Study Incorporating Pegylated Interferon In The Treatment For Children With High-Risk Melanoma

Diseases

Solid Tumor : Melanoma

Description

Melanoma in the pediatric population is rare. It represents 1-3 percent of all pediatric cancers. Most melanomas are localized and are cured with surgical excision alone. However, the presence of thick lesions (greater than 4 millimeters [mm] with ulceration) or spread to lymph node and other sites of the body are often associated with a high risk of disease recurrence (return).  This study is for children with these high risk features or who have recurrent disease.  The study has two treatment groups based on the stage of the disease.  Patients with stage IIC, IIIA or IIIB melanoma whose tumors have been removed by surgery will be treated in study group A.  These patients will receive 4 weeks of high dose interferon followed by 48 weeks of peginterferon.  Patients with stage IIIC or IV melanoma, stage III melanoma that could not be removed by surgery and those with recurrent disease will be treated in study group B.  These patients will receive peginterferon and temozolomide.


Objectives

  • To learn the effects on the melanoma of temozolomide given with peginterferon alpha-2b to pediatric patients
  • To learn the effects on the body of peginterferon given alone or with temozolomide to pediatric patients
  • To learn about how the body uses temozolomide and peginterferon (pharmacokinetics)
  • To study the effect of these drugs on the quality of life from the patient and parent perspective
  • To study the use of FDG PET/CT imaging in patients with high-risk cutaneous melanoma

Eligibility

  • Age less than or equal to 21 years of age at diagnosis
  • A confirmed diagnosis of cutaneous (skin) melanoma
  • Adequate liver, kidney, and bone marrow function
  • No active infection or unstable medical condition prior to enrollment
  • Participant meets other requirements defined in the eligibility portion of the study
  • Participant is able to perform ordinary tasks and daily activities as defined in the study guidelines

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).


Contact Information

Fariba Navid, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
Voice:   1-866-2ST-JUDE
             (1-866-278-5833)
FAX:     901-521-9005

Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

Amendment 1.0 dated 6.06.08, IRB approved 8.19.08


The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Email This Article Email This Article   |   Print Print