Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors
NCT00030667CI-TRIAL-00017516completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Desmoplastic Small Round Cell Tumor | Childhood Desmoplastic Small Round Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Synovial Sarcoma | Childhood Synovial Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Lung Metastases | — | UNRESOLVED | — |
| Recurrent Childhood Soft Tissue Sarcoma | Childhood Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | CURATED_BROADER | 0.78 |
| Recurrent Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
| Recurrent Osteosarcoma | Osteosarcoma | CURATED_BROADER |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (imatinib mesylate)
- description
- 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.
- interventionNames
- Drug: imatinib mesylate
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (2)
- measure
- Response rate, determined using the RECIST criteria
- timeFrame
- Up to 2 years
- description
- 95% confidence interval will be computed.
- measure
- Toxicity reported using the CTC version 2.0
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.