Imatinib treatment as therapy of neurofibromas in patients with NF1

• Conditions: Patients with NF1 and plessiform neurofibromas; MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000869-21-IT
• Lead Sponsor: ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

clinical diagnosis of NF1 according US National Institute of Health Consensus criteria, age at entry >3 < 65, and the presence of a measurable disabling or disfiguring plexiform neurofiroma that is not amenable to total surgical resection. Disabling PNF is defined as a tumor causing motor weakness by compression of the spinal cord or pain due to infiltration of spinal roots or limitation of limb mobility due to local mass effect. Disfiguring PNF is defined as an infiltranting tumor in the head and neck region with major cosmetic impairment, resulting in distress to the patient. Patients have to have a Lasky (children < 10 years) or Karnofsky (patients > 10 years) performance levels > 50. Radiographic progression is not a necessity for patient entry.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients undergoing radiation,chemotherapy, hormonal therapy, directed to the tumor or immunotherapy were excluded from partecipation. Other exclusion criteria are the presence of an active optic glioma or other tumor requiring radiation or chemotherapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified