Phase I Study of Ipilimumab (Anti-CTLA-4) in Children and Adolescents With Treatment-Resistant Cancer

Completed · Phase 1

Conditions studied: Sarcoma, Wilm's Tumor, Lymphoma, Neuroblastoma

In brief

This study will examine the safety and efficacy of ipilimumab-an experimental cancer treatment drug used to boost immune response-in children, adolescents, and young adults. Ipilimumab may allow immune cells to react to and destroy abnormal cells in the body, and has been tested in adults for a variety of cancers and has shown responses in some research studies. Because ipilimumab has not been tested in children, adolescents, or young adults, it is considered an experimental drug. The purposes of this research study are to determine the highest safe dose of ipilimumab for children, adolescents, and young adults with solid tumor cancers; examine its effectiveness and possible side effects; and better understand how the body and the immune system process it over time. Candidates must be between 2 and 21 years of age and must have solid malignant tumors that have been resistant to standard therapy. Volunteers will be screened with a medical history, a clinical examination, and computerized scans such as magnetic resonance imaging (MRI). Participants must have completed their last dose of chemotherapy, radiation, chemotherapy, or antibody or investigational therapy at least four weeks prior to enrollment. During the study, participants will receive an intravenous dose of ipilimumab once every three weeks. The infusion of ipilimumab will last 90 minutes, and the participant s vital signs will be monitored while the medicine is infusing and several times in the first 24 hours after the first dose (requiring a hospital stay during that time). If the participant is able to tolerate the first dose of ipilimumab, further doses (called cycles ) may be received on an outpatient basis. Blood and urine tests will be given on a regular basis during these cycles. After four cycles, participants whose tumors do not grow and who do not have unacceptable side effects will continue to receive ipilimumab every three months to maintain the current condition, until researchers conclude the study.

Key facts

Study ID

NCT01445379

Run by

National Cancer Institute (NCI)

People needed

33

Starts

2007-10-01

Expected to finish

2015-11-13

Last updated by the study team

2019-12-17

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Primary brain tumors
• Clinically significant unrelated systemic illness, such as serious infections or organ dysfunction, which in the judgment of the Principal or Associate Investigators would compromise the patient s ability to tolerate the agents in this trial or are likely to interfere with the study procedures or results. This includes but is not limited to:
• Critically-ill or medically unstable patients
• Patients with active infection or other significant systemic illness
• Patients with active diarrhea
• Patients with active eye inflammation, uveitis
• Presence of a symptomatic pleural effusion
• Patients with symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance
• History of malignant hyperthermia
• Concurrent or history of autoimmune disease excluding stable asthma
• Positive direct Coombs testing or history of hemolytic anemia
• Patients with a history of ongoing or intermittent bowel obstruction
• Concurrent radiation
• Patients with a history of allogeneic bone marrow transplantation.
• Untreated CNS metastases will render the patient ineligible however 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 progression in residual brain abnormalities without specific therapy are eligible one week post radiation or radiosurgery. Patients with asymptomatic subcentemeric CNS lesions will be eligible for trial if no immediate radiation or surgery.
• Patients with a history of previous therapy with ipilimumab will be excluded from study participation.
• Treatment with any of the following immunomodulatory agents within 14 days prior to study entry:
• -Systemic corticosteroid therapy
• --Erythropoeitin
• Retinoic acid
• Fenretinide
• Interferons or interleukins
• Cytokine-fusion proteins
• Growth hormone
• IVIG

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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