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Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00417807
First Posted: January 4, 2007
Last Update Posted: December 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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

Condition Intervention Phase
Refractory Desmoplastic Small Round Cell Tumors Drug: Imatinib mesilate Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall tumor response rates [ Time Frame: Assessed every 3 months ]
    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 [ Time Frame: Survival data was collected until death ]
    Recorded survival after treatment and other associated treatment modalities.

  • Safety and tolerability [ Time Frame: 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.

  • Mutational analysis of molecular targets of imatinib (at any time during the study) [ Time Frame: At any time during the study ]

Enrollment: 9
Study Start Date: August 2005
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gleevec/Glivec Drug: Imatinib mesilate
Other Name: STI571

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417807


Locations
Italy
Novartis Investigative Site
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 Stie
Vatania, Italy
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00417807     History of Changes
Other Study ID Numbers: CSTI571BIT06
First Submitted: January 2, 2007
First Posted: January 4, 2007
Last Update Posted: December 24, 2010
Last Verified: December 2010

Keywords provided by Novartis:
refractory desmoplastic small round cell tumors
PDGF-R

Additional relevant MeSH terms:
Desmoplastic Small Round Cell Tumor
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action