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Pediatric Cancers

A Phase I Study of Ipilimumab (Anti-CTLA-4) in Children, Adolescents, and Young Adults With Treatment Refractory Cancer

NCI-08-C-0007, NCT00556881

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Investigator(s):

Melinda Merchant, M.D.
Principal Investigator
Phone: 301-443-7955
Fax: 301-451-7014
melinda.merchant@nih.gov

Referral Contact(s):

Pediatric Oncology
Phone: 301-496-4256
1-877-624-4878 (Toll free)

 

Background:

  • Solid tumors represent approximately one-fourth of cancer diagnoses in children
  • Despite intensive regimens, patients with metastatic or recurrent solid tumors have unsatisfactory survival rates, and new therapies are needed to improve outcomes
  • Accumulating preclinical and clinical evidence supports the use of biologic approaches to heighten antitumor immunity in order to improve the effectiveness of immune-based therapy
  • Both directly activating immune-based therapies, such as cytokines and tumor vaccines, as well as therapies that disrupt negative counter-regulatory signals, such as those mediated by CTLA-4:B7, may enhance existent antitumor immune responses
  • Antibodies directed against CTLA-4 potently augment immune responses in animal models, and anti-CTLA-4 antibodies have demonstrated antitumor effects in a variety of preclinical tumor models
  • Phase I and Phase II studies using ipilimumab have been performed in adults with a variety of tumor types; clinical responses have been observed in renal cell carcinoma, melanoma, and prostate cancer
  • No trials have yet been performed to evaluate ipilimumab in children with malignancy

Objectives:

  • Determine the tolerance and toxicity profile of ipilimumab at a range of doses up to, but not exceeding, the highest dose tolerated in adults, in patients ≤ 21 years of age with refractory solid tumors
  • Assess the pharmacokinetics of ipilimumab administered intravenously in patients ≤ 21 years of age with advanced and/or refractory solid tumors

Key Eligibility Criteria:

  • Patients must be 1–21 years of age at the time of enrollment with solid malignant tumors refractory to standard therapy

Study Outline:

  • A Phase I dose-finding study with three planned dose levels
  • Three patients will be enrolled at each dose level with an expanded cohort of up to 12 at the highest dose or maximum tolerated dose with intent to include 6 patients < 12 years of age
  • Re-induction with 4 infusions of ipilimumab at the assigned dose followed by another maintenance phase is possible for subjects who have progressed during maintenance therapy

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.
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Reviewed: 12/14/12
Updated: 1/7/13

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