Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00417807
First received: January 2, 2007
Last updated: December 23, 2010
Last verified: December 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Recorded survival after treatment and other associated treatment modalities.

  • Safety and tolerability [ Time Frame: Safety data collected until patients were no longer in study ] [ Designated as safety issue: Yes ]
  • Conversion rate to surgical resectability [ Time Frame: After best tumor response. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00417807     History of Changes
Other Study ID Numbers: CSTI571BIT06
Study First Received: January 2, 2007
Last Updated: December 23, 2010
Health Authority: Italy: Minister of Health (AIFA)

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014