Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	30 and under	NCI	COG-ADVL0122 ADVL0122, NCT00030667

Objectives

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

Entry 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

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

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/mm³*
• Platelet count ≥ 75,000/mm³* (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

Expected Enrollment

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

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.

Bond M, Bernstein ML, Pappo A, et al.: A phase II study of imatinib mesylate in children with refractory or relapsed solid tumors: a Children's Oncology Group study. Pediatr Blood Cancer 50 (2): 254-8, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Mason Bond, MD, Protocol chair		Ph: 604-875-2406

Registry Information
Official Title		A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children with Refractory or Relapsed Solid Tumors
Trial Start Date		2002-05-06
Registered in ClinicalTrials.gov		NCT00030667
Date Submitted to PDQ		2001-12-13
Information Last Verified		2004-09-08
NCI Grant/Contract Number		U10-CA13539

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