Lymphoma Clinical Trial
Official title:
A Phase I Study of Ipilimumab (Anti-CTLA-4) in Children, Adolescents, and Young Adults With Treatment Refractory Cancer
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.
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. Therefore 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 which disrupt negative counterregulatory 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:
To 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 less than or equal to 21
years of age with refractory solid tumors.
To assess the pharmacokinetics of ipilimumab administered intravenously in patients less than
or equal to 21 years of age with advanced and/or refractory solid tumors.
Eligibility:
Patients must be 1-21 years of age at the time of enrollment with solid malignant tumors
refractory to standard therapy.
Design:
A Phase I dose finding study with 4 planned dose levels.
Three patients will be enrolled at each dose level with an expanded cohort of 12 at the
highest or maximum torlerated dose with intent to include 6 patients < 12 years.
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.
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