Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia

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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