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Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

NCT ID: NCT00417807

Last Updated: 2010-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Refractory Desmoplastic Small Round Cell Tumors

Keywords

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refractory desmoplastic small round cell tumors PDGF-R

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gleevec/Glivec

Group Type EXPERIMENTAL

Imatinib mesilate

Intervention Type DRUG

Interventions

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Imatinib mesilate

Intervention Type DRUG

Other Intervention Names

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STI571

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigative Site

Ivrea, , Italy

Site Status

Novartis Investigative Site

Milan, , Italy

Site Status

Novartis Investigative Site

Napoli, , Italy

Site Status

Novartis Investigative Site

Padua, , Italy

Site Status

Novartis Investigative Site

Ravenna, , Italy

Site Status

Novartis Investigative Site

Rozzano, , Italy

Site Status

Novartis Investigative Site

Torino, , Italy

Site Status

Novartis Investigative Stie

Vatania, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CSTI571BIT06

Identifier Type: -

Identifier Source: org_study_id