Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Refractory Desmoplastic Small Round Cell Tumors

Treatments: Drug: Imatinib mesilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00417807

CSTI571BIT06

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Gleevec/Glivec

Experimental group

Treatment:

Drug: Imatinib mesilate