MELBMS: Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma

Categories:

Solid Tumor

Diseases Treated:

Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma

Eligibility Overview:

  • Participant does not have a history of or current immunodeficiency disease, splenectomy or splenic irradiation
  • Participant does not have primary ocular melanoma
  • Participant does not have an uncontrolled infectious disease
  • Participant has not had a prior allogeneic stem cell transplant

Description

This is a non-randomized, multicenter, open label Phase 2 study in adolescent subjects (12 to <18 years of age) with previously treated or untreated unresectable Stage III or Stage IV malignant melanoma. This study will enroll approximately 30 patients.

Objectives

  • To estimate the survival rate at 1 year in adolescent patient (12 to < 18 years) with previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma.
  • To assess safety and tolerability, specifically the frequency of severe (grade 3-5) immune-mediated adverse reactions of ipilimumab in adolescent patients (12 to <18 years) at the 10 mg/kg dose level.

Eligibility Criteria among other include:

  • Participant does not have any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of side effects, such as a condition associated with frequent diarrhea
  • Participant does not have a history of or current immunodeficiency disease, splenectomy or splenic irradiation
  • Participant does not have primary ocular melanoma
  • Participant does not have an uncontrolled infectious disease
  • Participant has not had a prior allogeneic stem cell transplant

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

Alberto Pappo, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

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

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.