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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01445379
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Dose Level Escalation: 1mg/kg, 3mg/kg, 5mg/kg, 10mg/kg

Study Details

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 Dates

Start date
Oct 1, 2007
Status verified
Nov 2015
Primary completion
Apr 18, 2014
Completion
Nov 13, 2015

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Ipilumumab (DSE) given on day 1 of 21 day cycle for 4 cycles, from cycle 5+ ipilumumab will be given \~every 12wks

Primary Outcome Measure

To determine the tolerance and toxicity profile [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-

Find similar trials in Bethesda, MD

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MDDana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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