NCT04593589

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 head-and-neck-cancer

Timeline
31mo left

Started May 2022

Longer than P75 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
May 2022Jan 2029

First Submitted

Initial submission to the registry

September 4, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 10, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Expected
Last Updated

October 22, 2024

Status Verified

September 1, 2024

Enrollment Period

3.6 years

First QC Date

September 4, 2020

Last Update Submit

October 18, 2024

Conditions

Head and Neck Cancer

Keywords

RadiotherapyCell transplantationStem cell therapy

Outcome Measures

Primary Outcomes (2)

  • Safety: adverse events

    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).

    Data for assessing safety will be recorded from day 1 to 365.

  • Feasibility: salivary flow rate

    The salivary flow rate of the remaining submandibular gland will be recorded.

    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.

Secondary Outcomes (6)

  • 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

  • Locoregional control

    5 years after postoperative (chemo)radiation

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Transplantation

EXPERIMENTAL

Submandibular Gland Stem Cell Transplantation

Other: Submandibular Gland Stem Cell Transplantation

Interventions

Submandibular Gland Stem Cell TransplantationOTHER

Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy

Transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCG

Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • R.J.H.M. Steenbakkers, MD, PhD

    UMC Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

R.J.H.M. Steenbakkers, MD, PhD

CONTACT

+31 (0)503610034r.steenbakkers@umcg.nl

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

October 20, 2020

Study Start

May 10, 2022

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2029

Last Updated

October 22, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)