Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

This study has been terminated.
(stopped due to slow recruitment and no effect)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00427583
First received: January 25, 2007
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors


Condition Intervention Phase
Malignant Peripheral Nerve Sheath Tumors
Drug: imatinib mesylate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated. [ Time Frame: Every 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression assessed by an MRI scan. [ Time Frame: Every 36 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 36 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs [ Time Frame: Every 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2006
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STI571 Drug: imatinib mesylate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00427583

Locations
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00427583     History of Changes
Other Study ID Numbers: CSTI571BDE57
Study First Received: January 25, 2007
Last Updated: August 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Malignant,
peripheral,
nerve sheath tumors,
MPNST,
neurofibromatosis,
NF1,
Imatinib mesylate

Additional relevant MeSH terms:
Nerve Sheath Neoplasms
Neurofibrosarcoma
Neurilemmoma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
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
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroma
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014