Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00427583

Collaborator

(none)

Enrollment

Locations

Arm

5.5

Patients Per Site

Study Details

Study Description

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

Study Type:

Interventional

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 1, 2006

Actual Primary Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STI571	Drug: imatinib mesylate

Arm

Intervention/Treatment

Experimental: STI571

Drug: imatinib mesylate

Outcome Measures

Primary Outcome Measures

Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated. [Every 36 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.