Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia

Related Clinical Trial
Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL. A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia Frontline Oral Arsenic Trioxide for APL A Study of CG-806 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Total Marrow Irradiation for Refractory Acute Leukemia Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant MEK Inhibitor MEK162, Idarubicin, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies Decitabine and Total-Body Irradiation Followed By Donor Bone Marrow Transplant and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy A Phase II Study Of The Farnesyltransferase Inhibitor ZANESTRA (R115777, NSC #702818, IND #58,359) In Complete Remission Following Induction And/Or Consolidation Chemotherapy In Adults With Poor-Risk Acute Myelogenous Leukemia (AML) And High-Risk Myelodysplasia (MDS) Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With Acute Myeloid Leukemia Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia GTI-2040 in Treating Patients With Relapsed, Refractory, or High-Risk Acute Leukemia, High-Grade Myelodysplastic Syndromes, or Refractory or Blastic Phase Chronic Myelogenous Leukemia PXD101 in Treating Patients With Acute Myeloid Leukemia Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies Lenalidomide and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Bendamustine and Idarubicin in Treating Older Patients With Previously Untreated AML or MDS Clofarabine and Cytarabine in Treating Patients With Acute Myeloid Leukemia With Minimal Residual Disease Total Marrow and Lymphoid Irradiation and Chemotherapy Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Lymphocytic or Myelogenous Leukemia Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia Sirolimus and Azacitidine in Treating Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia That is Recurrent or Not Eligible for Intensive Chemotherapy AR-42 and Decitabine in Treating Patients With Acute Myeloid Leukemia CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Tosedostat in Combination With Cytarabine or Decitabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Decitabine, Donor Natural Killer Cells, and Aldesleukin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Selinexor and Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Decitabine and Bortezomib in Treating Patients With Acute Myeloid Leukemia Cediranib Maleate in Treating Patients With Relapsed, Refractory, or Untreated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome SJG-136 in Treating Patients With Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndromes, Blastic Phase Chronic Myelogenous Leukemia, or Chronic Lymphocytic Leukemia Daunorubicin Hydrochloride, Cytarabine and Oblimersen Sodium in Treating Patients With Previously Untreated Acute Myeloid Leukemia GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia Lenalidomide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia Connect® MDS/AML Disease Registry Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia Vorinostat in Treating Patients With Acute Myeloid Leukemia Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission Clofarabine, Cytarabine, and Filgrastim Followed by Infusion of Non-HLA Matched Ex Vivo Expanded Cord Blood Progenitors in Treating Patients With Acute Myeloid Leukemia Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly Comparison of Diagnostic Yield Among M-FISH, FISH Probe Panel and Conventional Cytogenetic Analysis in AML Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia Red Cell Transfusion Goals in Patients With Acute Leukemias A PALG Prospective Multicenter Clinical Trial to Compare the Efficacy of Two Standard Induction Therapies (DA-90 vs DAC) and Two Standard Salvage Regimens (FLAG-IDA vs CLAG-M) in AML Patients ≤ 60 Years Old An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML Phase I/II Trial of ATRA and TCP in Patients With Relapsed or Refractory AML and no Intensive Treatment is Possible Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia Pilot Clinical Trial of Pazopanib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible A Safety Study of SGN-CD33A in AML Patients FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy Biomarkers in Bone Marrow Samples From Patients With Acute Promyelocytic Leukemia Treatment Study for Children and Adolescents With Acute Promyelocitic Leukemia A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia ASCT for Relapsed APL After Molecular Remission Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup All-trans Retinoic Acid, and Arsenic +/- Idarubicin Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL Randomized,International Multi-center Clinical Trial of RIF Plus RA for Non-high-risk APL Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia AIDA 2000 Guidelines Tretinoin, Cytarabine, and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia The Acute Promyelocytic Leukaemia Asian Consortium (APL-AC) Project Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL French Registry of First-line Treatment of Acute Promyelocytic Leukemia New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO) Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005) Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF) Treatment of Acute Promyelocytic Leukemia With All-Trans Retinoic Acid (ATRA) and Idarubicin (AIDA) Single Agent Arsenic Trioxide in the Treatment of Newly Diagnosed Acute Promyelocytic Leukemia Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia Treatment Protocol for Relapsed Acute Promyelocytic Leukemia (APL) With Arsenic Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia Role of Microparticles in the Coagulopathy of Acute Promyelocytic Leukemia Proteasome Inhibition in Acute Promyelocytic Leukemia

Brief Title

Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia

Official Title

A Phase I Study of PS-341 (Velcade, Bortezomib) in Pediatric Patients With Refractory/Recurrent Leukemias

Brief Summary

      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.
    

Detailed Description

      OBJECTIVES: Primary I. Determine the maximum tolerated dose and recommended phase II dose of
      bortezomib in children with refractory or recurrent leukemia.

      II. Determine the toxic effects of this drug in these patients. III. Determine the
      pharmacokinetics of this drug in these patients.

      Secondary I. Determine, preliminarily, the antitumor activity of this drug in these patients.

      II. Determine, preliminarily, the biologic activity of this drug in these patients.

      OUTLINE: This is a dose-escalation, open-label, multicenter study.

      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.

      Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1.5-36
      months.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum tolerated dose and recommended phase II dose

Secondary Outcome

 Antitumor activity

Condition

Blastic Phase Chronic Myelogenous Leukemia

Intervention

bortezomib

Study Arms / Comparison Groups

 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

36

Start Date

January 2004


Primary Completion Date

March 2006

Eligibility Criteria

        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
      

Gender

All

Ages

1 Year - 21 Years

Accepts Healthy Volunteers

No

Contacts

Terzah Horton, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00077467

Organization ID

NCI-2012-01809

Secondary IDs

ADVL0317

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Terzah Horton, Principal Investigator, COG Phase I Consortium


Verification Date

June 2013