Status:
COMPLETED
Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Refractory Desmoplastic Small Round Cell Tumors
Eligibility:
All Genders
16+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 treate...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients \> 16 years of age.
- Histologically documented diagnosis of DSRCT, unresponsive or in no complete remission after any conventional multimodality approach.
- Immunohistochemical documentation of activated PDGF-R expression by tumor
- At least one measurable site of disease
- Performance status 0,1, 2 or 3 (Eastern Cooperative Oncology Group)
- Adequate end organ function
- Exclusion criteria:
- Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
- Patient is \< 5 years free of another primary malignancy
- Patient with congestive heart failure or myocardial infarction within 6 months of study
- Female patients who are pregnant or breast-feeding.
- Severe and/or uncontrolled medical disease
- Known brain metastasis.
- Chronic active hepatitis or cirrhosis
- Known diagnosis of human immunodeficiency virus (HIV) infection.
- Chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
- Previous radiotherapy to \> 25 % of the bone marrow
- Major surgery within 2 weeks prior to study entry.
- Other protocol defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00417807
Start Date
August 1 2005
Last Update
December 24 2010
Active Locations (8)
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1
Novartis Investigative Site
Ivrea, Italy
2
Novartis Investigative Site
Milan, Italy
3
Novartis Investigative Site
Napoli, Italy
4
Novartis Investigative Site
Padua, Italy