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STI571 in Treating Patients With Recurrent Leukemia
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 17, 2009   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004932
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: imatinib mesylate
Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Imatinib Imatinib mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of STI571 in Ph+ Leukemia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004932

  Show 235 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Martin Champagne, MD Hopital Sainte Justine
  More Information

Additional Information:
Publications:
Champagne MA, Capdeville R, Krailo M, Qu W, Peng B, Rosamilia M, Therrien M, Zoellner U, Blaney SM, Bernstein M; Children's Oncology Group phase 1 study. Imatinib mesylate (STI571) for treatment of children with Philadelphia chromosome-positive leukemia: results from a Children's Oncology Group phase 1 study. Blood. 2004 Nov 1;104(9):2655-60. Epub 2004 Jul 1.
Champagne MA, Hershon L, Rosamilia M, et al.: STI571 in the Treatment of Pediatric Philadelphia (Ph+) Chromosome-Positive Leukemia: A Children's Oncology Group Phase 1 Study (P-9973). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1466, 2001.

Study ID Numbers: CDR0000067616, COG-P9973, POG-9973, CCG-P9973
Study First Received: March 7, 2000
Last Updated: February 17, 2009
ClinicalTrials.gov Identifier: NCT00004932     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
relapsing chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
childhood chronic myelogenous leukemia

Study placed in the following topic categories:
Philadelphia Chromosome
Acute Lymphoblastic Leukemia, Childhood
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Protein Kinase Inhibitors
Recurrence
Imatinib
Acute Myeloid Leukemia, Childhood
Leukemia
Acute Myelocytic Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:
Imatinib
Leukemia
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009