Clinical trial · Interventional
Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors
Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R
NCT00417807CI-TRIAL-00004226completedPhase 1 / Phase 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)
An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Desmoplastic Small Round Cell Tumors | Desmoplastic Small Round Cell Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib mesilate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gleevec/Glivec
- interventionNames
- Drug: Imatinib mesilate
Primary outcomes (1)
- measure
- Overall tumor response rates
- timeFrame
- Assessed every 3 months
- description
- An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.
Secondary outcomes (4)
- measure
- Explore how Imatinib cooperated with other treatment modatilities
- timeFrame
- Survival data was collected until death
- description
- Recorded survival after treatment and other associated treatment modalities.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion criteria: 1. Patients \> 16 years of age. 2. Histologically documented diagnosis of DSRCT, unresponsive or in no complete remission after any conventional multimodality approach. 3. Immunohistochemical documentation of activated PDGF-R expression by tumor 4. At least one measurable site of disease 5. Performance status 0,1, 2 or 3 (Eastern Cooperative Oncology Group) 6. Adequate end organ function Exclusion criteria: 1. Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing. 2. Patient is \< 5 years free of another primary malignancy 3. Patient with congestive heart failure or myocardial infarction within 6 months of study 4. Female patients who are pregnant or breast-feeding. 5. Severe and/or uncontrolled medical disease 6. Known brain metastasis. 7. Chronic active hepatitis or cirrhosis 8. Known diagnosis of human immunodeficiency virus (HIV) infection. 9. Chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing. 10. Previous radiotherapy to \> 25 % of the bone marrow 11. Major surgery within 2 weeks prior to study entry. Other protocol defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.