A Phase I Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of Lymfactin® (AdAptVEGF-C Adenoviral Vector) in Combination With a Surgical Lymph Node Transfer for the Treatment of Patients With Secondary Lymphedema
Overview
- Phase
- Phase 1
- Intervention
- Lymfactin® [1 x 10E10 vp]
- Conditions
- Secondary Lymphedema
- Sponsor
- Herantis Pharma Plc.
- Enrollment
- 15
- Locations
- 3
- Primary Endpoint
- Biodistribution of Lymfactin in blood
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Lymfactin® [1 x 10E10 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.
Intervention: Lymfactin® [1 x 10E11 vp]
Outcomes
Primary Outcomes
Biodistribution of Lymfactin in blood
Time Frame: 90 days
Changes in Lymfactin genome copy number in blood
CT scan of chest and abdomen
Time Frame: 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
Time Frame: 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
Time Frame: 6 months
Changes in the anti-Lymfactin antibody titer in blood
Secondary Outcomes
- Measurement of the volume of the arms(baseline, 6, 12, 24 and 36 months)
- 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)
- Questionnaire according to the Lymphedema Quality of Life Inventory (LQOLI)(baseline, 6, 12, 24 and 36 months)