Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

NCT00427583 | Terminated Phase 2

• 1 other identifier: CSTI571BDE57
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Malignant Peripheral Nerve Sheath Tumors

Keywords

Malignant,; peripheral,; nerve sheath tumors,; MPNST,; neurofibromatosis,; NF1,; Imatinib mesylate

Outcome Measures

Primary Outcomes (1)

• Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated.

  Every 36 weeks

Secondary Outcomes (3)

• Time to progression assessed by an MRI scan.

  Every 36 weeks

• Overall survival

  Every 36 weeks

• Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs

  Every 36 weeks

Study Arms (1)

STI571

EXPERIMENTAL

Drug: imatinib mesylate

Interventions

imatinib mesylate DRUG

STI571

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Hamburg, Germany

Location

MeSH Terms

Conditions

Neurofibrosarcoma; Nerve Sheath Neoplasms; Neurofibromatoses

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Fibrosarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neurofibroma; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: May 1, 2006
• Primary Completion: April 1, 2009
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

DE (2)