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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00030667

Run by

National Cancer Institute (NCI)

People needed

100

Starts

2002-05-01

Expected to finish

2005-12-01

Last updated by the study team

2015-04-15

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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