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Investigator(s):
Crystal  Mackall, M.D. Principal Investigator Phone: 301-402-5940 mackallc@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• Histologically confirmed solid tumors, which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing’s sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilm’s tumor, Hodgkin's or non-Hodgkin's lymphoma
• Patients with melanoma are eligible
• Measurable or evaluable disease, relapsed or refractory to standard treatment and/or no known curative therapy for current disease state
• No untreated central nervous system (CNS) metastasis
• Patients with a previous history of CNS metastases are eligible if the metastases have been treated with surgery and/or radiotherapy, are clinically stable as evidenced by no requirements for corticosteroids, the patient has no evolving neurologic deficits and no change in residual brain abnormalities without specific therapy over 6 weeks
• No primary brain tumors
• ≥ 2 years and ≤ 21 years of age
• ≥ 4 weeks since prior irradiation, chemotherapy, monoclonal antibody, or investigational therapy
• ≥ 3 months since prior autologous stem cell transplantation
• No concurrent radiotherapy, chemotherapy, immunotherapy, or other investigational agent
• No prior allogeneic bone marrow transplantation
• No prior ipilimumab
• Karnofsky performance status (PS) ≥ 50% (patients < 10 years of age) OR Lansky PS > 50% (patients ≤ 10 years of age)
• Peripheral absolute granulocyte count ≥ 1,000/μL
• Hemoglobin ≥ 8 g/dL
• Platelet count ≥ 75,000/μL (transfusion independent)
• AST and ALT ≤ 2.5 x upper limit of normal (ULN)
• Direct bilirubin normal
• Normal age-adjusted serum creatinine OR creatinine clearance ≥ 70 mL/min/1.73 m²
• Not pregnant or nursing
• Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control which includes abstinence, while they are being treated on this study and for 60 days following the last dose. Females of childbearing potential must have a negative pregnancy test within 14 days prior to initiation of study therapy and prior to each additional dose of ipilimumab
• Negative for hepatitis A , B, C, and HIV
• No active infection or other significant systemic illness that would preclude study participation
• Patients who are ≥ 18 years of age will be offered the opportunity to assign a DPA so that another person can make decisions about their medical care if they become incapacitated or cognitively impaired

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Study Outline:

Induction therapy:

• Patients receive ipilimumab intravenously (IV) over 90 minutes on Day 1
• Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity

Maintenance therapy:

• Beginning in course 5 and all subsequent courses, patients receive ipilimumab IV over 90 minutes on Day 1 every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity



• Patients undergo blood sample collection periodically for pharmacokinetic studies
• After completion of study treatment, patients are followed, if possible, for 3 weeks following the last dose of ipilimumab or when the patient is removed from study, regardless of the reason for coming off study, unless the test or procedure has been performed in the past 2 weeks

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/8/09
Updated: 7/30/09