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Proteasome Inhibitor

Bortezomib 1.3mg/m2-assess efficacy-low anthracycline exposure for Acute Promyelocytic Leukemia

Phase 2
Waitlist Available
Led By Jeffrey Moscow
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, prior to and up to 24 hours after bortezomib treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This phase II trial is studying the side effects and best dose of bortezomib and to see how well it works when given together with combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may kill more cancer cells

Eligible Conditions
  • Acute Promyelocytic Leukemia
  • Childhood Acute Erythroleukemia
  • Leukemia
  • Acute Myeloid Leukemia
  • Adult Acute Myeloid Leukemia
  • Acute Myelomonocytic Leukemia
  • Acute Basophilic Leukemia
  • Childhood Leukemia
  • Monoblastic Leukemia
  • Monocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Limiting Toxicity
Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1
Secondary study objectives
Feasibility of Stem Cell Quantitation: Percentage of Leukemia Initiation Cells (LIC) Depletion
NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)
Proteasome Inhibition Activity
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Bortezomib 1.3mg/m2-assess efficacy-low anthracycline exposureExperimental Treatment4 Interventions
Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age \< 3 years old.
Group II: Bortezomib 1.3 mg/m2-assess feasibility high anthracycline expExperimental Treatment4 Interventions
Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).
Group III: Bortezomib 1.3 mg/m2-assess efficacy high anthracycline expExperimental Treatment4 Interventions
Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity
Group IV: Bortezomib 1.0mg/m2-assess feasibility high anthracycline expExperimental Treatment4 Interventions
Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idarubicin
FDA approved
Cytarabine
FDA approved
Etoposide
FDA approved
Bortezomib D-mannitol
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,899 Previous Clinical Trials
41,014,017 Total Patients Enrolled
Jeffrey MoscowPrincipal InvestigatorChildren's Oncology Group
~3 spots leftby Oct 2025
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