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Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

Primary Purpose

Refractory Desmoplastic Small Round Cell Tumors

Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Imatinib mesilate
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Desmoplastic Small Round Cell Tumors focused on measuring refractory desmoplastic small round cell tumors, PDGF-R

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Stie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gleevec/Glivec

Arm Description

Outcomes

Primary Outcome Measures

Overall tumor response rates
An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.

Secondary Outcome Measures

Explore how Imatinib cooperated with other treatment modatilities
Recorded survival after treatment and other associated treatment modalities.
Safety and tolerability
Conversion rate to surgical resectability
Assessed actual resectability rate after therapy compared to resectability before therapy.
Mutational analysis of molecular targets of imatinib (at any time during the study)

Full Information

First Posted
January 2, 2007
Last Updated
December 23, 2010
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00417807
Brief Title
Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors
Official Title
Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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 treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Desmoplastic Small Round Cell Tumors
Keywords
refractory desmoplastic small round cell tumors, PDGF-R

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gleevec/Glivec
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Imatinib mesilate
Other Intervention Name(s)
STI571
Primary Outcome Measure Information:
Title
Overall tumor response rates
Description
An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.
Time Frame
Assessed every 3 months
Secondary Outcome Measure Information:
Title
Explore how Imatinib cooperated with other treatment modatilities
Description
Recorded survival after treatment and other associated treatment modalities.
Time Frame
Survival data was collected until death
Title
Safety and tolerability
Time Frame
Safety data collected until patients were no longer in study
Title
Conversion rate to surgical resectability
Description
Assessed actual resectability rate after therapy compared to resectability before therapy.
Time Frame
After best tumor response.
Title
Mutational analysis of molecular targets of imatinib (at any time during the study)
Time Frame
At any time during the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmeceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Ivrea
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
Country
Italy
Facility Name
Novartis Investigative Site
City
Ravenna
Country
Italy
Facility Name
Novartis Investigative Site
City
Rozzano
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
Country
Italy
Facility Name
Novartis Investigative Stie
City
Vatania
Country
Italy

12. IPD Sharing Statement

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Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

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