Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030667
First received: February 14, 2002
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have relapsed or refractory solid tumors of childhood. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.


Condition Intervention Phase
Childhood Desmoplastic Small Round Cell Tumor
Childhood Synovial Sarcoma
Gastrointestinal Stromal Tumor
Lung Metastases
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Neuroblastoma
Recurrent Osteosarcoma
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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):

Primary Outcome Measures:
  • Response rate, determined using the RECIST criteria [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    95% confidence interval will be computed.

  • Toxicity reported using the CTC version 2.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to disease progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Calculated by the method of Kaplan and Meier.


Estimated Enrollment: 100
Study Start Date: May 2002
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (imatinib mesylate)
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.
Drug: imatinib mesylate
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed Description:

OBJECTIVES:

I. Determine the response rate of patients with relapsed or refractory pediatric solid tumors treated with imatinib mesylate.

II. Determine the toxicity of this drug in these patients. III. Determine the time to progression in patients treated with this drug. IV. Determine the pharmacokinetics of this drug in these patients. V. 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.

  Eligibility

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

Inclusion Criteria:

  • 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
    • At least 10 mm by spiral CT scan
    • Lesions assessable only by radionuclide scan are not considered measurable
  • Performance status - Lansky 50-100% (≤ 10 years of age)
  • Performance status - Karnofsky 50-100% (> 10 years of age)
  • At least 2 months
  • Absolute neutrophil count ≥ 1,000/mm^3*
  • Platelet count ≥ 75,000/mm^3* (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL* (RBC transfusions allowed)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN
  • INR < 1.5
  • PTT ≤ ULN
  • Fibrinogen ≥ lower limit of normal
  • Creatinine normal for age
  • Glomerular filtration rate ≥ 70 mL/min
  • No uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • At least 1 week since prior biologic therapy or immunotherapy and recovered
  • At least 1 week since prior growth factors
  • No concurrent immunomodulating agents
  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No concurrent chemotherapy
  • No concurrent steroids
  • 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030667

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Investigators
Principal Investigator: Mason Bond Children's Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030667     History of Changes
Other Study ID Numbers: NCI-2012-01869, NCI-2012-01869, CDR0000069187, COG-ADVL0122, ADVL0122, ADVL0122, U10CA098543
Study First Received: February 14, 2002
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma
Gastrointestinal Stromal Tumors
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Osteosarcoma
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma, Synovial
Neoplasms
Desmoplastic Small Round Cell Tumor
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Bone Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014