Panitumumab in Children With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: Panitumumab
Intervention description: Panitumumab administered by intravenous infusion
Intervention MeSH terms: Panitumumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Epidermal Growth Factor; Pediatric; Solid Tumors; Panitumumab; Dose Limiting Toxicity

Summary:

      The primary objective of this study was to evaluate the safety and pharmacokinetics of up to
      3 different dose schedules of panitumumab in pediatric patients with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parents or legal guardian signed-written informed consent

          -  1 to < 18 years of age

          -  Histologically or cytologically confirmed solid tumor that has recurred after standard
             therapy, or for which there is no standard therapy. Subjects with brainstem glioma DO
             NOT need histologic proof of the diagnosis.

          -  Paraffin-embedded tumor tissue from primary tumor or metastasis for determination of
             epidermal growth factor receptor expression and biomarker testing

          -  Central nervous system tumors are allowed

          -  Presence of measurable or non-measurable disease.

          -  Life expectancy of ≥ 12 weeks.

          -  Performance status: Karnofsky ≥ 60% for 12 to <18 years of age; Lansky play scale ≥
             60% for 1 to < 12 years of age.

          -  Adequate hematologic function.

          -  Adequate renal function.

          -  Adequate hepatic function.

          -  Magnesium ≥ lower limit of normal (LLN)

          -  Adequate pulmonary function

          -  All previous therapy-related toxicities must have resolved or return to baseline.

        Exclusion Criteria:

          -  Diagnosis of leukemia, non-Hodgkin's lymphoma, Hodgkin's disease or other hematologic
             malignancy.

          -  Any prior allogeneic transplant.

          -  Prior autologous bone marrow or peripheral stem cell transplant less than 3 months
             prior to enrollment.

          -  Substantial radiotherapy to the bone marrow within 6 weeks prior to enrollment.

          -  Prior use of any monoclonal antibodies directly targeting the epidermal growth factor
             receptor (EGFr). Subjects who have received prior tyrosine kinase inhibitors such as
             gefitinib or erlotinib are eligible.

          -  Immunotherapy, radiotherapy, or chemotherapy ≤ 2 weeks prior to enrollment. (≤ 6 weeks
             for nitrosoureas, mitomycin-C, and liposomal doxorubicin, and ≤ 6 weeks from prior
             antibody therapy).

          -  Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy (except
             for pain control) or any other investigational drug while on this study.

          -  Prior seizures < 3 months prior to enrollment. Subjects with a history of seizure
             disorders ≥ 3 months prior to enrollment must be seizure free and on stable
             anticonvulsant medication(s) for ≥ 3 months prior to enrollment).

          -  Presence of a serious uncontrolled medical disorder.

          -  Dementia, altered mental status, or any other medical condition or disorder that would
             prohibit the understanding or rendering of assent (if applicable), or ability to
             comply with study procedures.

          -  Major surgery ≤ 28 days prior to enrollment.

          -  Known or suspected history of interstitial lung disease.

          -  Active inflammatory bowel disease or other bowel disease causing chronic diarrhea.

          -  Known positive test for human immunodeficiency virus infection, hepatitis C virus,
             acute or chronic hepatitis B infection, or any co-morbid disease that would increase
             risk of toxicity.

          -  Females of childbearing potential not using adequate contraception precautions for the
             duration of the study treatment and for 2 months after the last administration of
             investigational product.

          -  Pregnant or breast-feeding, or planning to become pregnant during study treatment and
             within 2 months after the last administration of investigational product.

          -  Received investigational therapy or procedure ≤ 30 days prior to enrollment.