Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
Phase II Trial of Gleevec (Formerly Known as STI571) in Patients With Soft Tissue and Bone Sarcomas: A Multi-Disciplinary Trial of the North American Sarcoma Study Group of the Connective Tissue Oncology Society
NCT00031915CI-TRIAL-00010804completedPhase 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)
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma.
Conditions
Conditions (2)
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 Malignant Fibrous Histiocytoma of Bone | Childhood Undifferentiated High Grade Pleomorphic Sarcoma of Bone | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic or unresectable locally advanced (stage IV or recurrent) soft tissue or bone sarcoma
* Eligible subtypes:
* Ewing's family (e.g., primitive neuroectodermal tumor)
* Osteosarcoma
* Synovial sarcoma
* Rhabdomyosarcoma (e.g., alveolar, embryonal, or pleomorphic)
* Liposarcoma (all variants)
* Malignant fibrous histiocytoma
* Peripheral nerve sheath (e.g., malignant peripheral nerve sheath tumor, neurofibrosarcoma, or schwannoma)
* Fibrosarcoma
* Angiosarcoma (all variants)
* Failed standard therapy with no available salvage regimens
* Unidimensionally measurable target lesions by x-ray, CT scan, MRI, PET, or physical examination
* Must be outside prior irradiation fields or have documented disease progression at least 6 weeks after completion of prior radiotherapy
PATIENT CHARACTERISTICS:
Age:
* 10 and over
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 3 times upper limit of normal (ULN)
* ALT and AST less than 2.5 times ULN
Renal:
* Creatinine less than 1.5 times ULN
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 1 week after study participation for female patients and for at least 3 months after study participation for male patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* No hormonal birth control
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* At least 28 days since any prior systemic therapyReferences
Publications (1)
- RESULTChugh R, Wathen JK, Maki RG, Benjamin RS, Patel SR, Meyers PA, Priebat DA, Reinke DK, Thomas DG, Keohan ML, Samuels BL, Baker LH. Phase II multicenter trial of imatinib in 10 histologic subtypes of sarcoma using a bayesian hierarchical statistical model. J Clin Oncol. 2009 Jul 1;27(19):3148-53. doi: 10.1200/JCO.2008.20.5054. Epub 2009 May 18. PMID 19451433