Clinical trial · Interventional
Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
A Phase I Study of PS-341 (Velcade, Bortezomib) in Pediatric Patients With Refractory/Recurrent Leukemias
NCT00077467CI-TRIAL-00010605completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blastic Phase Chronic Myelogenous Leukemia | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Childhood Acute Promyelocytic Leukemia (M3) | Childhood Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Recurrent Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Childhood Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: bortezomib
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Maximum tolerated dose and recommended phase II dose
- timeFrame
- Up to 21 days
- measure
- Toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 3.0
- timeFrame
- Up to 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * Recovered from prior immunotherapy * At least 7 days since prior filgrastim (G-CSF) or sargramostim (GM-CSF) * At least 7 days since prior biologic agents * At least 3 months since prior stem cell transplantation or rescue and no evidence of active graft-versus-host disease * No concurrent prophylactic G-CSF during course 1 of study * No concurrent immunotherapy * No concurrent biologic therapy * Recovered from prior chemotherapy * At least 24 hours since prior hydroxyurea for cytoreduction * At least 6 weeks since prior nitrosoureas * No concurrent chemotherapy * At least 7 days since prior steroids (except as premedication prior to blood product transfusion) * Recovered from prior radiotherapy * At least 2 weeks since prior small port local palliative radiotherapy * At least 3 months since prior total body irradiation, craniospinal irradiation, or irradiation to more than 50% of the pelvis * At least 6 weeks since other prior substantial bone marrow radiotherapy * No concurrent radiotherapy * At least 7 days since prior retinoids * No other concurrent investigational agents * No other concurrent anticancer agents * No concurrent anticonvulsant medications known to activate the cytochrome p450 system (e.g., phenytoin, carbamazepine, or phenobarbital) * Concurrent benzodiazepines and gabapentin are allowed
References
Publications (0)
Data not yet available
No reference posted for this study.