RESTART: Submandibular Gland Stem Cell Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transplantation Submandibular Gland Stem Cell Transplantation |
Other: Submandibular Gland Stem Cell Transplantation
Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy
|
Outcome Measures
Primary Outcome Measures
- Safety: adverse events [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).
- Feasibility: salivary flow rate [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.
Secondary Outcome Measures
- Salivary flow recovery [Saliva measurements at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation]
Unstimulated whole saliva, paraffin stimulated whole saliva and 5% citric acid stimulated parotid and submandibular/sublingual saliva measurements.
- 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]
Patient-rated outcome measures including various side effects related to the postoperative (chemo)radiation and Quality of Life (QoL) using internationally validated questionnaires.
- Locoregional control [5 years after postoperative (chemo)radiation]
Locoregional control is defined as the number of patients with recurrent disease within or adjacent to the primary tumor site and regional lymph nodes after postoperative (chemo)radiation, assessed by pathology and/or oncologic imaging (CT, MRI or PET).
- Overall survival and disease-free survival [5 years after postoperative (chemo)radiation]
- Rate of water diffusion in remaining submandibular gland [6 and 12 months after postoperative (chemo)radiation]
The rate of water diffusion in remaining submandibular gland derived from DWI/DTI-MRI.
- Amount of PSMA [6 and 12 months after autologous stem cell transplantation]
The amount of prostate specific membrane antigen (PSMA) in the remaining submandibular gland derived from PET-CT
Eligibility Criteria
Criteria
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).
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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);
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Age ≥ 18 years;
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WHO performance 0-2;
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Written informed consent;
Exclusion Criteria:
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Primary (definitive) radiotherapy, with or without systemic treatment;
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Previous radiotherapy of the head and neck region (re-irradiation);
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Positive microbiological screening for Human Immunodeficiency Virus type 1 and 2, hepatitis B and C virus and Treponema pallidum.
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Presence of systemic disease known to affect salivary gland functioning (e.g., Sjögren's syndrome);
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Known allergy to mice and gentamicin
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History within the past five years of malignancies other than:
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basal or squamous cell carcinoma of the skin
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in situ carcinoma of the cervix;
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Females who are pregnant or lactating at entry.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UMCG | Groningen | Netherlands |
Sponsors and Collaborators
- University Medical Center Groningen
Investigators
- Principal Investigator: R.J.H.M. Steenbakkers, MD, PhD, UMC Groningen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RT2020-04