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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030667 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor Metastatic Cancer Neuroblastoma Sarcoma |
Drug: imatinib mesylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | 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 |
| Study Start Date: | May 2002 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumors including the following:
Metastatic pulmonary disease eligible
Recurrent or refractory to conventional therapy
At least 1 measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 233 Study Locations| Study Chair: | Mason Bond, MD | Children's and Women's Hospital of British Columbia |
More Information
| ClinicalTrials.gov Identifier: | NCT00030667 History of Changes |
| Other Study ID Numbers: | CDR0000069187, COG-ADVL0122 |
| Study First Received: | February 14, 2002 |
| Last Updated: | October 15, 2011 |
| Health Authority: | United States: Federal Government |
|
recurrent neuroblastoma recurrent osteosarcoma recurrent childhood soft tissue sarcoma childhood synovial sarcoma |
childhood desmoplastic small round cell tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor gastrointestinal stromal tumor lung metastases |
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neuroblastoma Gastrointestinal Stromal Tumors Sarcoma Neoplastic Processes Pathologic Processes Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Neoplasms, Connective and Soft Tissue Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |