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A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors


Phase 2
N/A
30 Years
Open (Enrolling)
Both
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

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Trial Information

A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate, determined using the RECIST criteria

Outcome Description:

95% confidence interval will be computed.

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Mason Bond

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01869

NCT ID:

NCT00030667

Start Date:

May 2002

Completion Date:

Related Keywords:

  • 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
  • Neoplasm Metastasis
  • Neuroblastoma
  • Osteosarcoma
  • Sarcoma, Synovial
  • Lung Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Sarcoma
  • Gastrointestinal Stromal Tumors
  • Desmoplastic Small Round Cell Tumor
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral

Name

Location

Children's Oncology GroupArcadia, California  91006-3776