Bevacizumab in Treating Young Patients With Refractory Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Childhood Solid Tumor, Protocol Specific
In brief
This phase I trial is studying the side effects and best dose of bevacizumab in treating young patients with refractory solid tumors. Monoclonal antibodies, such as bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
Key facts
- Study ID
- NCT00085111
- Run by
- National Cancer Institute (NCI)
- People needed
- 24
- Starts
- 2003-12-01
- Last updated by the study team
- 2013-06-05
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed solid tumor at original diagnosis
- Measurable or evaluable* disease
- No known curative therapy exists
- No lymphomas or primary CNS tumors
- No history or clinical evidence of CNS metastasis by head CT scan
- Performance status - Karnofsky 50-100% (patients > 10 years of age)
- Performance status - Lansky 50-100% (patients ≤ 10 years of age)
- At least 8 weeks
- Patients without bone marrow involvement:
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3 (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (RBC transfusion allowed)
- Patients with bone marrow metastases:
- Platelet count ≥ 75,000/mm\^3 (transfusion independent)
- Granulocytopenia, anemia, and/or mild thrombocytopenia allowed
- No known bleeding diathesis or coagulopathy
- No known thrombophilic condition (e.g., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocystinemia, or antiphospholipid antibody syndrome)
- PT or PTT ≤ 1.2 times upper limit of normal (ULN)
- ALT ≤ 5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Albumin ≥ 2 g/dL
- Creatinine clearance or radioisotope glomerular filtrationrate ≥ 70 mL/min
- Creatinine based on age as follows:
- Creatinine ≤ 0.8 mg/dL (patients ≤ 5 years of age)
- Creatinine ≤ 1.0 mg/dL (patients 6 to 10 years of age)
Where it is running
- COG Phase I Consortium — Arcadia, California, United States
Full record on ClinicalTrials.gov
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