A PHASE I STUDY OF IPILIMUMAB (ANTI-CTLA-4) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH TREATMENT REFRACTORY CANCER - Ipilimumab in Pediatric Patients

ational Cancer Institute NCI0 sites27 target enrollmentSeptember 18, 2012

ConditionsSarcoma - Wilm's Tumor - Lymphoma - Neuroblastoma MedDRA version: 17.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: N/A
Intervention: Not specified
Conditions: Sarcoma - Wilm's Tumor - Lymphoma - Neuroblastoma
Sponsor: ational Cancer Institute NCI
Enrollment: 27
Status: Active, Not Recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 18, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ational Cancer Institute NCI

Eligibility Criteria

Inclusion Criteria

•AGE: Patients must be greater than or equal to 2 years and less than or equal to 21 years of age.
•DIAGNOSIS: 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.
•MEASURABLE/EVALUABLE DISEASE: Patients must have measurable or evaluable tumors.
•PRIOR THERAPY:
•The patient's cancer must have relapsed following or failed to respond to standard therapy and/or the patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival.
•Patients must have completed their last dose of chemotherapy, monoclonal antibody, or investigational therapy at least 4 weeks prior to enrollment and patients that received irradiation must have completed therapy at least one week prior to enrollment. Biologic or other approved molecular targeted small molecule inhibitors with a short half\-life
•must be stopped at least 1 week prior to enrollment. For patients who have undergone autologous stem cell transplantation, at least 3 months must have elapsed since transplant.
•Patients must have recovered from the toxic effects (to a grade 1 or less) of all prior therapy prior to enrollment, with the exception of the following:
•?Hematological toxicity: recovery to levels required below
•?Low electrolyte levels (Such individuals should receive appropriate supplementation)

Exclusion Criteria

•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