Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

December 23, 2010 updated by: Novartis Pharmaceuticals

Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ivrea, Italy
        • Novartis Investigative Site
      • Milano, Italy
        • Novartis Investigative Site
      • Napoli, Italy
        • Novartis Investigative Site
      • Padova, Italy
        • Novartis Investigative Site
      • Ravenna, Italy
        • Novartis Investigative Site
      • Rozzano, Italy
        • Novartis Investigative Site
      • Torino, Italy
        • Novartis Investigative Site
      • Vatania, Italy
        • Novartis Investigative Stie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gleevec/Glivec
Drug: Imatinib mesilate
Other Names:
  • STI571

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall tumor response rates
Time Frame: Assessed every 3 months
An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.
Assessed every 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explore how Imatinib cooperated with other treatment modatilities
Time Frame: Survival data was collected until death
Recorded survival after treatment and other associated treatment modalities.
Survival data was collected until death
Safety and tolerability
Time Frame: Safety data collected until patients were no longer in study
Safety data collected until patients were no longer in study
Conversion rate to surgical resectability
Time Frame: After best tumor response.
Assessed actual resectability rate after therapy compared to resectability before therapy.
After best tumor response.
Mutational analysis of molecular targets of imatinib (at any time during the study)
Time Frame: At any time during the study
At any time during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 2, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

December 24, 2010

Last Update Submitted That Met QC Criteria

December 23, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSTI571BIT06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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