Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Feasibility: salivary flow rate
Study Overview
Brief Summary
This study is a phase I safety and feasibility study to treat head and neck cancer patients with autologous salivary gland stem cell transplantation after postoperative (chemo)radiotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Squamous cell carcinoma (SCC) originating from the mucosa of the oral cavity;
- •Primary resection of tumour including an electively or therapeutic ipsilateral neck dissection (at least levels Ib to III, including the submandibular gland).
- •Postoperative radiotherapy or chemoradiation, including prophylactic or therapeutic irradiation of the contralateral side of the neck (where the remaining submandibular gland is), including at least levels Ib to IV), next to irradiation of the tumour bed and ipsilateral neck (current standard);
- •Age ≥ 18 years;
- •WHO performance 0-2;
- •Written informed consent;
Exclusion Criteria
- •Primary (definitive) radiotherapy, with or without systemic treatment;
- •Previous radiotherapy of the head and neck region (re-irradiation);
- •Positive microbiological screening for Human Immunodeficiency Virus type 1 and 2, hepatitis B and C virus and Treponema pallidum.
- •Presence of systemic disease known to affect salivary gland functioning (e.g., Sjögren's syndrome);
- •Known allergy to mice and gentamicin
- •History within the past five years of malignancies other than:
- •basal or squamous cell carcinoma of the skin
- •in situ carcinoma of the cervix;
- •Females who are pregnant or lactating at entry.
Outcomes
Primary Outcomes
Feasibility: salivary flow rate
Time Frame: Data for assessing feasibility will be recorded 6 and 12 months after autologous stem cell transplantation to assess if salivary flow will be increased compared to salivary flow before transplantation.
The salivary flow rate of the remaining submandibular gland will be recorded.
Safety: adverse events
Time Frame: Data for assessing safety will be recorded from day 1 to 365.
The number of adverse events (AE), serious adverse events (SAE) or suspected unexpected adverse reactions (SUSAR) after autologous salivary stem cell transplantation. All possible adverse events will be scored according to the definitions of the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0).
Secondary Outcomes
- Salivary flow recovery(Saliva measurements at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation)
- Impact of transplantation(Patient-rated outcome measures at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation)
- Overall survival and disease-free survival(5 years after postoperative (chemo)radiation)
- Amount of PSMA(6 and 12 months after autologous stem cell transplantation)
- Locoregional control(5 years after postoperative (chemo)radiation)
- Rate of water diffusion in remaining submandibular gland(6 and 12 months after postoperative (chemo)radiation)