Solid Tumor (Childhood)
Phase I Trial of Monoclonal Antibody HGS-ETR2 (Lexatumumab) in Patients With Refractory Pediatric Solid Tumors
NCI-07-C-0040
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Investigator(s): |
Crystal Mackall, M.D.
Principal Investigator
Phone: 301-402-5940
mackallc@mail.nih.gov
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Pediatric Oncology
Phone: 1-877-624-4878
(Toll free)
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Primary Eligibility:
- ≥ 1 years and ≤ 21 years of age
- Histologically confirmed malignancy, including, but not limited to, any of the following:
- Rhabdomyosarcoma and other soft tissue sarcoma
- Ewing’s sarcoma family of tumors
- Osteosarcoma
- Neuroblastoma
- Wilms tumor
- Hodgkin’s lymphoma
- Non-Hodgkin’s lymphoma
- Measurable or evaluable disease
- Must have relapsed after or failed to respond to prior standard therapy
- No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
- No primary or metastatic hepatic tumors
- No primary or untreated metastatic CNS tumors
- At least 3 months since prior autologous stem cell transplantation
- No prior allogeneic bone marrow transplantation
- Karnofsky performance status (PS) 50-100% (patients > 10 years of age) OR Lansky PS 50-100% (patients ≤ 10 years of age)
- Absolute granulocyte count ≥ 1,000/mm3, platelet count ≥ 75,000/mm3 (transfusion independent), hemoglobin ≥ 8 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal, bilirubin normal
- Creatinine clearance ≥ 60 mL/min OR creatinine normal
- No known HIV infection, no immune deficiency, no hepatitis B or C
Treatment Plan:
This is an open-label, dose-escalation study.
- Patients receive lexatumumab IV over 1 hour on days 1 and 15
- Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
- Groups of 3-6 patients receive escalating doses of lexatumumab until the maximum tolerated dose (MTD) is determined
- Up to 12 patients may be treated at the MTD, including at least 6 patients who are ≤ 12 years of age
- After completion of study therapy, patients are followed periodically
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 11/11/08
Updated: 4/30/07
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