Summary

for people ages 12 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

This study, designed as a proof of concept study of MCS110 in pigmented villonodular synovitis, will assess the clinical response to MCS110 treatment in newly diagnosed Pigmented Villonodular Synovitis (PVNS) patients within 4 weeks after a single intravenous dose of MCS110 using magnetic resonance imaging to assess tumor volume, and to evaluate pharmacokinetics/pharmacodynamics, safety and tolerability in this population.

Official Title

A Phase II Randomized, Double -Blind, Placebo Controlled Study to Assess Safety, Tolerability and Effect on Tumor Size of MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)

Keywords

Pigmented Villonodular Synovitis PVNS Giant Cell Tumor of the Tendon Sheath GCCTS Tenosynovial Giant Cell Tumor Localized or Diffused Type GCTS Tenosynovial giant cell tumor (localized or diffused type) MCS110 Neoplasms Synovitis Giant Cell Tumors Giant Cell Tumor of Tendon Sheath Synovitis, Pigmented Villonodular

Eligibility

You can join if…

Open to people ages 12 years and up

  • Patients with newly diagnosed PVNS with, at least, one measurable site of disease on MRI.
  • Patients expected to get surgery.
  • Vital signs within the ranges: systolic blood pressure 80-150 mmHg , diastolic blood pressure 50-100 mmHg, pulse rate 40-100 bpm, oral body temperature 35.0-37.5°C.
  • Patients with normal level of serum ionized calcium and phosphate.
  • Women of child-bearing potential must use highly effective contraception during the study and for 84 days after the study drug infusion.

You CAN'T join if...

  • Patients with major surgery less than 3 months prior to start study drug or who have still side effects of such therapy.
  • Presence of systemic illness precluding definitive surgery or increasing the risk to patients due to potential immunosuppression.
  • Use previously of intra-articular treatment within 4 weeks prior dosing.
  • Patients with dermal change indicative of lymphedema or phlebolymphedema. disease.
  • Patients with elevated troponin T and/or CK levels (> 1.5 x ULN for the laboratory) or with history of myositis, rhabdomyolysis or other myopathic disease.
  • Patients receiving immunosuppressive treatment as well as corticosteroids which cannot be discontinued at least 4 weeks before dosing.
  • Patients engaged in a resistance exercise training program.
  • Patients with pacemakers or any metallic objects as exclusion for MRI
  • Patients with concomitant disease know to get influence on bone metabolism
  • Patients who have history of drug or alcohol abuse within 12 months prior study dosing.
  • Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.

Locations

  • Novartis Investigational Site - UCSD
    San Diego California 92103-8894 United States
  • Novartis Investigative Site
    San Diego California 92103-8894 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
Links
Ann Oncol. 2008 Apr;19(4):821-2. Epub 2008 Feb 21; Complete response to imatinib in relapsing pigmented villonodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT)
ID
NCT01643850
Phase
Phase 2
Study Type
Interventional
Last Updated
August 13, 2018