Ipilimumab in Young Patients With Advanced or Refractory Solid Tumors

Status: Recruiting
Phase: Phase 1
Diagnosis: Pediatric Hodgkin Lymphoma, Pediatric Neuroblastoma, Pediatric Sarcoma, Pediatric Solid Tumors, Pediatric Lymphoma, Pediatric Wilms' Tumor
NCT ID: NCT00556881 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-062


RATIONALE: Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of ipilimumab in treating children, adolescents, and young adults with advanced or refractory solid tumors,


Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Carlos Rodriguez-Galindo, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

DISEASE CHARACTERISTICS: Inclusion criteria: - Histologically confirmed solid tumors including, but not limited to, any of the following: - Melanoma - Rhabdomyosarcoma or other soft tissue sarcomas - Ewing sarcoma family of tumors - Osteosarcoma - Neuroblastoma - Wilms tumor - Hodgkin or non-Hodgkin lymphoma - Measurable or evaluable disease - Must meet at least 1 of the following criteria: - Relapsed disease - Failed to respond to standard therapy - No known curative therapy for current disease state or no known curative therapy proven to prolong survival - Patients with a prior history of CNS metastases are eligible provided the following criteria are met: - Metastases have been treated with surgery and/or radiotherapy - Clinically stable as evidenced by no requirements for corticosteroids - No evolving neurologic deficits and no progression in residual brain abnormalities without specific therapy over the past 4 weeks Exclusion criteria: - Primary brain tumors - Untreated CNS metastases PATIENT CHARACTERISTICS: Inclusion criteria: - Karnofsky performance status (PS) ≥ 50% (patients > 10 years of age) OR Lansky PS > 50% (patients ≤ 10 years of age) - Patients who are unable to walk because of paralysis or weakness, but who are up in a wheelchair will be considered ambulatory for the purpose of calculating the performance score - Peripheral absolute granulocyte count ≥ 1,000/μL - Hemoglobin ≥ 8 g/dL - Platelet count ≥ 75,000/μL (transfusion independent) - AST and ALT ≤ 2.5 times upper limit of normal - Direct bilirubin normal - Creatinine clearance ≥ 70 mL/min OR maximum serum creatinine meeting the following criteria: - 0.8 mg/dL (≤ 5 years of age) - 1.0 mg/dL (> 5 or ≤ 10 years of age) - 1.2 mg/dL (> 10 or ≤ 15 years of age) - 1.5 mg/dL (> 15 years of age) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 60 days after completion of study therapy - Negative hepatitis A (anti-hepatitis A IgM), B, (HBsAg), and C (anti-HCV) - A positive hepatitis B titer does not exclude a patient if immunization has been performed and if there is no history of disease - Negative HIV Exclusion criteria: - Clinically significant unrelated systemic illness, such as serious infections or organ dysfunction, which in the judgment of the principle 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 including, but not limited to, any of the following: - Critically ill or medically unstable - Active infection or other significant systemic illness - Active diarrhea - Active eye inflammation or uveitis - Presence of a symptomatic pleural effusion - Symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance - History of malignant hyperthermia - Prior or concurrent autoimmune disease excluding stable asthma - Positive direct Coombs testing or history of hemolytic anemia - History of ongoing or intermittent bowel obstruction - Autoimmune disease, including any of the following: - Hemolytic anemia - Ulcerative or hemorrhagic colitis - Endocrine disorders (e.g., thyroiditis, hyperthyroidism, hypothyroidism, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency) - Sarcoid granuloma - Myasthenia gravis - Polymyositis - Guillain-Barre syndrome PRIOR CONCURRENT THERAPY: Inclusion criteria: - See Disease Characteristics - Must have recovered from the toxic effects (grade ≤ 1) of all prior therapy except for any of the following: - Hematological toxicity - Low electrolyte levels (such individuals should receive appropriate supplementation) - For patients on anticoagulant therapy or with pre-existing coagulation abnormalities, PT and PTT must return to baseline - Liver function tests must be resolved - Grade 3 hypoalbuminemia - Alopecia - Sterility - At least 4 weeks since prior chemotherapy, monoclonal antibody, or investigational therapy - At least 1 week since prior radiotherapy - At least 3 months since prior autologous stem cell transplantation Exclusion criteria - Concurrent radiotherapy - Prior allogeneic bone marrow transplantation - Prior ipilimumab - Treatment with any of the following within 14 days prior to study : - Systemic corticosteroid therapy - Erythropoietin - Retinoic acid - Fenretinide - Interferons or interleukins - Cytokine-fusion proteins - Growth hormone - Intravenous immunoglobulin - Treatment with myeloid growth factors (G-CSF [filgrastim]/GM-CSF [sargramostim]) within 72 hours prior to study - Concurrent chemotherapy or immunotherapy - Any other concurrent investigational agent
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