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

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Research

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Protocol

MELBMS: 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

Diseases

Solid Tumor : Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma

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
FAX: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@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.

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