Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
Completed · Phase 1
Conditions studied: Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Promyelocytic Leukemia (M3), Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia
In brief
This phase I trial is studying the side effects and best dose of bortezomib in treating young patients with refractory or recurrent leukemia. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
Key facts
- Study ID
- NCT00077467
- Run by
- National Cancer Institute (NCI)
- People needed
- 36
- Starts
- 2004-01-01
- 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 leukemia of 1 of the following types:
- Acute lymphoblastic leukemia
- Acute myeloid leukemia
- Chronic myelogenous leukemia in blast crisis
- Relapsed or refractory disease
- Immunophenotypically confirmed disease, either at initial diagnosis or relapse
- More than 25% blasts in the bone marrow (M3 bone marrow)
- Active extramedullary disease (except leptomeningeal disease) allowed
- No known curative therapy or therapy proven to prolong survival with an acceptable quality of life available
- Performance status - Karnofsky 50-100% (for patients age 11 to 21)
- Performance status - Lansky 50-100% (for patients age 10 and under)
- Platelet count ≥ 20,000/mm\^3*
- Hemoglobin ≥ 8.0 g/dL*
- WBC < 20,000/mm\^3** (hydroxyurea for cytoreduction allowed)
- No hyperleukocytosis (i.e., WBC > 100,000/mm\^3)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 5 times ULN
- Albumin ≥ 2 g/dL
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
- Creatinine based on age as follows:
- ≤ 0.8 mg/dL for patients age 5 and under
- ≤ 1.0 mg/dL for patients age 6 to 10
- ≤ 1.2 mg/dL for patients age 11 to 15
- ≤ 1.5 mg/dL for patients age 16 to 21
- Not pregnant or nursing
Where it is running
- COG Phase I Consortium — Arcadia, California, United States
Full record on ClinicalTrials.gov
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