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STI571 in Treating Patients With Recurrent Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00004932
First received: March 7, 2000
Last updated: February 20, 2014
Last verified: February 2014

March 7, 2000
February 20, 2014
January 2002
September 2005   (final data collection date for primary outcome measure)
Survival [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
To estimate the maximum tolerated dose (MTD) of STI571 administered orally once daily without interruption to children with recurrent Ph+ leukemia.
Not Provided
Complete list of historical versions of study NCT00004932 on ClinicalTrials.gov Archive Site
  • Dose-limiting toxicities [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
    To determine the dose-limiting toxicities (DLT) of STI571 given on this schedule.
  • Characterize the pharmacokinetic behavior [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
    To characterize the pharmacokinetic behavior of STI571 in children with recurrent Ph+ leukemia.
  • Define the anti-leukemic activity of STI571 [ Time Frame: Length of study ] [ Designated as safety issue: No ]
    To preliminarily define the anti-leukemic activity of STI571 within the confines of a Phase I study.
Not Provided
Not Provided
Not Provided
 
STI571 in Treating Patients With Recurrent Leukemia
A Phase I Study of STI571 in Ph+ Leukemia

RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia.

PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia.

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with recurrent Philadelphia chromosome-positive leukemia.
  • Characterize the pharmacokinetic behavior of this drug in this patient population.
  • Determine preliminarily the antileukemic activity of this drug in these patients.

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

Patients receive oral imatinib mesylate (STI571) once daily for 28 days. Treatment continues in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study within 3.5 years.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
Drug: imatinib mesylate
Other Names:
  • CGP 57148
  • IND # 55666
  • Experimental: 260 mg/m2 imatinib mesylate (ST571)
    Intervention: Drug: imatinib mesylate
  • Experimental: 340 mg/m2 imatinib mesylate (ST571)
    Intervention: Drug: imatinib mesylate
  • Experimental: 440 mg/m2 imatinib mesylate (ST571)
    Intervention: Drug: imatinib mesylate
  • Experimental: 570 mg/m2 imatinib mesylate (ST571)
    Intervention: Drug: imatinib mesylate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2005
September 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Recurrent Philadelphia (Ph) chromosome-positive leukemia

    • Recurrent or refractory acute lymphoblastic or myeloblastic leukemia OR
    • Chronic myelogenous leukemia with resistance to interferon alfa with any of the following:

      • WBC at least 20,000/mm^3 after at least 3 months of interferon therapy
      • At least 100% increase in WBC to at least 20,000/mm^3 confirmed over 2 weeks while receiving interferon alfa
      • At least 66% Ph chromosome-positive cells after 1 year of interferon therapy
      • At least 30% increase in number of Ph chromosome-positive cells after an interferon-induced response while continuing interferon therapy

PATIENT CHARACTERISTICS:

Age:

  • Under 22

Performance status:

  • Karnofsky 50-100% if over 10 years of age OR
  • Lansky 50-100% if 10 years of age and under

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGPT less than 3 times normal
  • Albumin greater than 2 g/dL

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • If prior allogeneic stem cell transplantation, no uncontrolled graft-versus -host disease
  • No seizure disorder if on anticonvulsants
  • No uncontrolled infection
  • No CNS toxicity greater than grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 1 week since prior biologic therapy and recovered
  • At least 3 months since prior stem cell transplantation (SCT)
  • At least 1 week since prior growth factors
  • At least 1 week since prior interferon alfa

Chemotherapy:

  • Recovered from prior chemotherapy
  • At least 6 weeks since prior busulfan and nitrosoureas
  • At least 2 weeks since prior homoharringtonine
  • At least 1 week since low-dose cytarabine
  • At least 2 weeks since prior moderate-dose cytarabine
  • At least 4 weeks since prior high-dose cytarabine
  • At least 3 weeks since all other prior cytotoxic chemotherapies
  • No prior hydroxyurea

Endocrine therapy:

  • Must be on a stable dose of steroids if received prior allogeneic SCT

Radiotherapy:

  • Recovered from prior radiotherapy
  • At least 2 weeks since prior local palliative radiotherapy (small port)
  • At least 6 months since prior craniospinal radiotherapy
  • At least 6 months since prior radiotherapy to 50% or more of the pelvis
  • At least 6 weeks since other prior substantial bone marrow radiotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent investigational agents
  • No concurrent anticonvulsants
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00004932
P9973, COG-P9973, POG-9973, CCG-P9973, CDR0000067616
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Martin Champagne, MD Hopital Sainte Justine
Children's Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP