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Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

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.
 
ClinicalTrials.gov Identifier: NCT00427583
Recruitment Status : Terminated (stopped due to slow recruitment and no effect)
First Posted : January 29, 2007
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors

Condition or disease Intervention/treatment Phase
Malignant Peripheral Nerve Sheath Tumors Drug: imatinib mesylate Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Multicenter Phase II Study of Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
Study Start Date : May 2006
Actual Primary Completion Date : April 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: STI571 Drug: imatinib mesylate


Outcome Measures
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Primary Outcome Measures :
  1. Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated. [ Time Frame: Every 36 weeks ]

Secondary Outcome Measures :
  1. Time to progression assessed by an MRI scan. [ Time Frame: Every 36 weeks ]
  2. Overall survival [ Time Frame: Every 36 weeks ]
  3. Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs [ Time Frame: Every 36 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients ≥18 years of age
  • Histologically documented diagnosis of malignant MPNST
  • Unresectable local MPNST or metastatic MPNST and therefore incurable with any conventional multimodality approach Life expectancy of at least 6 months.

Exclusion criteria:

  • Patient has received any other investigational agents within 28 days of first day of study drug dosing.
  • Chemotherapy and or radiotherapy in between the last 6 weeks before study entry, surgery in between the last 14 days before study entry.
  • Female patients who are pregnant or breast feeding or women of child bearing potential who are not using a highly effective method of birth control.
  • Known CNS metastases

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations
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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): NCT00427583


Locations
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Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00427583    
Other Study ID Numbers: CSTI571BDE57
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Malignant,
peripheral,
nerve sheath tumors,
MPNST,
 neurofibromatosis,
NF1,
Imatinib mesylate
Additional relevant MeSH terms:
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Nerve Sheath Neoplasms
Neurofibrosarcoma
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Fibrosarcoma
 Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Neurofibroma
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action