A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema
- Conditions
- Secondary Lymphedema
- Interventions
- Drug: Lymfactin® [1 x 10E10 vp]Drug: Lymfactin® [1 x 10E11 vp]
- Registration Number
- NCT02994771
- Lead Sponsor
- Herantis Pharma Plc.
- Brief Summary
Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer.
Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer.
- Detailed Description
This is an open label, multi-center, uncontrolled first in human trial that uses a standard 3 + 3 dose escalation scheme. Lymfactin® will be administered as a single dose by ex vivo perinodal injection into the fat pad of a flap of tissue containing lymph nodes from the abdominal wall. This flap of tissue will then be surgically implanted into the axillary region of the affected arm. This treatment with Lymfactin® may be performed in conjunction with or without breast reconstruction surgery.
Up to two dose cohorts are planned to be included. Each dose of Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL:
* Cohort 1: Lymfactin® \[1 x 10E10 vp\]
* Cohort 2: Lymfactin® \[1 x 10E11 vp\]
Should the dose escalation go up to Cohort 2 with initiation of a subsequent Extension Cohort a total of 15 - 21 patients may be treated in this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lymfactin® [1 x 10E10 vp] Lymfactin® [1 x 10E10 vp] Lymfactin® \[1 x 10E10 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL. Lymfactin® [1 x 10E11 vp] Lymfactin® [1 x 10E11 vp] Lymfactin® \[1 x 10E11 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL.
- Primary Outcome Measures
Name Time Method Biodistribution of Lymfactin in blood 90 days Changes in Lymfactin genome copy number in blood
CT scan of chest and abdomen baseline, yearly up to 5 years Changes in the CT scan of chest and abdomen in order to detect malignancies
Safety as measured by number of patients with treatment related adverse events and serious adverse events as assessed by CTCAE v4.0 baseline to 1 year, yearly up to 5 years Adverse events and serious adverse events assessed by CTCAE v4.0 to evaluate the safety profile after administration of Lymfactin
Formation of anti-Lymfactin antibodies 6 months Changes in the anti-Lymfactin antibody titer in blood
- Secondary Outcome Measures
Name Time Method Measurement of the volume of the arms baseline, 6, 12, 24 and 36 months Changes in the volume of the affected arm and comparison to the unaffected arm
Measurement of the lymphatic flow of the affected arm by quantitative lymphoscintigraphy (99Tc-nanocolloid clearance rate with calculation of transport index) baseline, 12, 24 and 36 months Assessment of the changes in the lymphatic flow
Questionnaire according to the Lymphedema Quality of Life Inventory (LQOLI) baseline, 6, 12, 24 and 36 months Assessment of changes in the quality of life using Lymphedema Quality of Life Inventory (LQOLI) in which patients assess how their lymphedema is affecting the activities of daily living. LQOLI consists of three dimensions: Physical, psychosocial and practical, which are reported separately as the mean score of each dimension. Each dimension of the LQOLI is scored from 0 to 3, where score 0 means "no impact", 1 means "a little bit impact", 2 means "somewhat impact", and 3 means "significant impact" on the quality of life of the patient, the smaller score thus being the better.
Trial Locations
- Locations (3)
Toeoeloe Hospital, Department of Plastic Surgery
🇫🇮Helsinki, Finland
Turku University Hospital, Department of Plastic Surgery
🇫🇮Turku, Finland
Tampere University Hospital, Department of Plastic Surgery
🇫🇮Tampere, Finland