MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS) (NCT01643850) | Clinical Trial Compass
CompletedPhase 2
MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
United States, Switzerland36 participantsStarted 2012-04-23
Plain-language summary
This study, designed as a proof of concept study of MCS110 in pigmented villonodular synovitis, assessed the clinical response to MCS110 treatment in Pigmented Villonodular Synovitis (PVNS) patients, after a single or multiple intravenous doses of MCS110, using magnetic resonance imaging to assess tumor volume, and evaluated the pharmacokinetics/pharmacodynamics, safety and tolerability in this population.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Males and Females aged ≥ 18 years (≥ 12 years in PART C) with PVNS or GCTTS with, at least, one measurable site of disease on MRI.
* Patients expected to get surgery (PART A of study only).
* 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.
Exclusion criteria:
* 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 g…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
Timeframe: Week 4
2
Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
Timeframe: Week 4
3
Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size
Timeframe: Up to 8 weeks post last dose
4
Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size