Status:
COMPLETED
Panitumumab in Children With Solid Tumors
Lead Sponsor:
Amgen
Conditions:
Solid Tumors
Eligibility:
All Genders
1-17 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is an open-label, multi-center, single arm, dose-ranging, clinical study. Panitumumab will be administered by intravenous infusion to 4-6 patients per cohort. Three planned cohorts, stratified by...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00658658
Start Date
March 1 2008
End Date
March 1 2015
Last Update
May 18 2016
Active Locations (11)
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1
Research Site
Los Angeles, California, United States, 90027
2
Research Site
San Francisco, California, United States, 94143
3
Research Site
Washington D.C., District of Columbia, United States, 20010
4
Research Site
Chicago, Illinois, United States, 60611