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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.
Study NCT00030667   Information provided by National Cancer Institute (NCI)
First Received: February 14, 2002   Last Updated: July 23, 2008   History of Changes

February 14, 2002
July 23, 2008
May 2002
 
 
 
Complete list of historical versions of study NCT00030667 on ClinicalTrials.gov Archive Site
 
 
 
Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors

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.

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.

Phase II
Interventional
Treatment
  • Gastrointestinal Stromal Tumor
  • Metastatic Cancer
  • Neuroblastoma
  • Sarcoma
Drug: imatinib mesylate
 
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]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
up to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00030667
 
CDR0000069187, COG-ADVL0122
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Mason Bond, MD Children's & Women's Hospital of British Columbia
National Cancer Institute (NCI)
September 2004

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