BridgeMD
Tests treatment safety and results for Lymphatic Malformation
Official title Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations
ClinicalTrials.gov ID: NCT03243019
What this study is testing
What is rapamycin?
rapamycin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lymphatic malformation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- Patient from 0 to 18 years of age, presenting with poly-cystic suprahyoid or mediastinal lymphatic.
- with chronic pain or functional respiratory or swallowing impairment with a CDS score \< 8
- Curative treatment is not possible or associated with a high risk of morbidity ,mortality and functional and cosmetic impairment
- Karnofsky Score (\> 10 years of age) or Lansky score (≤10 years of age) \> 50%
- Biology
You likely can't join if
- Non-respect of inclusion criteria
- Other immunosuppressive therapy or long-term general corticosteroid therapy without a 28-day washout period
- renal failure
- Liver failure
- Digestive disease leading to rapamycin malabsorption
- uncontrolled or severe infectious disease
See the full eligibility criteria
- Patient from 0 to 18 years of age, presenting with poly-cystic suprahyoid or mediastinal lymphatic.
- with chronic pain or functional respiratory or swallowing impairment with a CDS score \< 8
- Curative treatment is not possible or associated with a high risk of morbidity ,mortality and functional and cosmetic impairment
- Karnofsky Score (\> 10 years of age) or Lansky score (≤10 years of age) \> 50%
- Biology
- Neutrophils count≥1.0 x 109/L
- Platelets count ≥ 100 x 109/L
- Hemoglobin ≥ 8 g/dL
- Bilirubin ≤ 1,5 ULN
- Transaminases \< 2,5 ULN
- Serum albumin ≥ 2 g/dL.
- LDL cholesterol \<160 mg/dL
- Triglycerides \< 150 mg/dL
- Negative test of pregnancy if relevant
- Social security affiliation
- At least 2 months after a previous procedure on the malformation
- Non-respect of inclusion criteria
- Other immunosuppressive therapy or long-term general corticosteroid therapy without a 28-day washout period
- renal failure
- Liver failure
- Digestive disease leading to rapamycin malabsorption
- uncontrolled or severe infectious disease
- Patients requiring treatment interfering with CYP3A4 isoenzyme (rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin) or inhibiting CYP3A4 isoenzyme's activity (ketoconazole, voriconazole, itraconazole...
- Concomitant administration of mTOR inhibitor
- Peanuts or soya allergy
- Impossibility to receive informed consent
- Absence of social security affiliation
- refusal to sign consent
- Ongoing pregnancy or breastfeeding
- refusal to participate
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.