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Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
This study is ongoing, but not recruiting participants.
First Received: February 14, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030667
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have relapsed or refractory solid tumors of childhood.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Metastatic Cancer
Neuroblastoma
Sarcoma
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors

Resource links provided by NLM:


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

Study Start Date: May 2002
Detailed Description:

OBJECTIVES:

  • Determine the response rate of patients with relapsed or refractory pediatric solid tumors treated with imatinib mesylate.
  • Determine the toxicity of this drug in these patients.
  • Determine the time to progression in patients treated with this drug.
  • Determine the pharmacokinetics of this drug in these patients.
  • Correlate response with c-kit and platelet-derived growth factor receptor expression in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma/primitive neuroectodermal tumor vs osteosarcoma vs neuroblastoma vs other).

Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A maximum of 100 patients (10-25 per stratum) will be accrued for this study within 12 to 18 months.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumors including the following:

    • Ewing's sarcoma
    • Bone or soft tissue primitive neuroectodermal tumor
    • Osteosarcoma
    • Neuroblastoma
    • Desmoplastic small round cell tumor
    • Synovial cell sarcoma
    • Gastrointestinal stromal tumor (GIST)
  • Metastatic pulmonary disease eligible

    • No pleural effusion of any size or definite radiologic evidence of pleural-based disease
  • Recurrent or refractory to conventional therapy

    • GIST eligible at initial presentation
  • Tumor tissue blocks must be available
  • At least 1 measurable lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • Lesions assessable only by radionuclide scan are not considered measurable

PATIENT CHARACTERISTICS:

Age:

  • 30 and under

Performance status:

  • Lansky 50-100% (≤ 10 years of age)
  • Karnofsky 50-100% (> 10 years of age)

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Absolute neutrophil count ≥ 1,000/mm^3*
  • Platelet count ≥ 75,000/mm^3* (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL* (RBC transfusions allowed) NOTE: *Unless due to bone marrow involvement

Hepatic:

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN
  • INR < 1.5
  • PTT ≤ ULN
  • Fibrinogen ≥ lower limit of normal

Renal:

  • Creatinine normal for age OR
  • Glomerular filtration rate ≥ 70 mL/min

Other:

  • No uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 1 week since prior biologic therapy or immunotherapy and recovered
  • At least 1 week since prior growth factors
  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent steroids

Radiotherapy:

  • Recovered from prior radiotherapy
  • At least 2 weeks since prior local palliative radiotherapy (small port)
  • At least 3 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of pelvis
  • At least 6 weeks since other prior substantial bone marrow radiation
  • No concurrent radiotherapy during first course of treatment
  • Concurrent palliative radiotherapy to local painful lesions allowed after first course of treatment provided there is no evidence of disease progression and at least 1 measurable lesion remains outside radiation port

Surgery:

  • Not specified

Other:

  • No concurrent therapeutic doses of warfarin
  • No concurrent anticonvulsants that induce the cytochrome p450 enzyme system (e.g., phenytoin, carbamazepine, and phenobarbital)
  • Concurrent benzodiazepines and gabapentin allowed
  • Concurrent low-molecular weight heparin allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030667

  Show 233 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Mason Bond, MD Children's & Women's Hospital of British Columbia
  More Information

Additional Information:
Publications:
Bond M, Bernstein ML, Pappo A, Schultz KR, Krailo M, Blaney SM, Adamson PC. A phase II study of imatinib mesylate in children with refractory or relapsed solid tumors: A Children's Oncology Group study. Pediatr Blood Cancer. 2007 Jan 29; [Epub ahead of print]
Bond M, Bernstein ML, Pappo A, et al.: Phase 2 trial of imatinib mesylate (IM) for treatment of recurrent or refractory pediatric solid tumors: a Children's Oncology Group Study. [Abstract] J Clin Oncol 23 (Suppl 16): A-8520, 805s, 2005.

Study ID Numbers: CDR0000069187, COG-ADVL0122
Study First Received: February 14, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00030667     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent neuroblastoma
recurrent osteosarcoma
recurrent childhood soft tissue sarcoma
childhood synovial sarcoma
childhood desmoplastic small round cell tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
gastrointestinal stromal tumor
lung metastases

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Neoplasms, Nerve Tissue
Protein Kinase Inhibitors
Neuroblastoma
Neoplasms, Connective and Soft Tissue
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neoplasms by Histologic Type
Digestive System Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Imatinib
Neuroectodermal Tumors
Neoplasms
Digestive System Diseases
Sarcoma
Gastrointestinal Neoplasms
Neoplasms, Neuroepithelial
Gastrointestinal Stromal Tumors
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on March 18, 2010