Back to resultsStudy Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
Primary Purpose
Head and Neck Cancer, Xerostomia
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MSC
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria: History of histological diagnosis of head and neck cancer (HNC) that was treated with radiation therapy and currently clinically or radiologically no evidence of disease (NED) Xerostomia, defined as patient reported salivary function (pre-treatment) ≤ 80% of healthy (pre-radiation) ≥ 18 years of age, ≤ 90 years of age. Patients ≥ 2 years from completion of radiation therapy for HNC Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia Willing and able to give informed consent Radiographically confirmed submandibular gland(s) Exclusion Criteria: Salivary gland disease (i.e., sialolithiasis)
Sites / Locations
- University of Wisconsin Carbone Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mesenchymal Stem Cell (MSC) injection
Arm Description
Outcomes
Primary Outcome Measures
Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)
RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT)
Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale
Incidence of pain assessed as greater than 5 on standard 0-10 point pain scale (0=not at all to 10=worst pain imaginable)
Safety and Tolerability: Number of Serious Adverse Events
Incidence of any serious adverse event
Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events
Incidence of pre-specified adverse events
Secondary Outcome Measures
Change in Quality of Life
Efficacy of MSC assessed through University of Michigan Xerostomia Related Quality of Life (XeQOL) scale, which is a 15-item assessment scale with 4 domains. The score is the average of all responses of all domains and can range from 0 to 4, where higher scores indicate increased xerostomia burden.
Change in Quality of Life
Efficacy of MSC assessed through the MD Anderson Dysphagia Index (MDADI), which is a 20-item questionnaire designed for evaluating the impact of dysphagia (swallowing ability). Scores range from 20 (extremely low functioning) to 100 (high functioning).
Change in Quality of Life
Efficacy of MSC assessed through VAS xerostomia questionnaire, which is an 8-item questionnaire that measures the perception of dry mouth. Scores range from 0-10, with 0 being low dryness and 10 being high dryness.
Change in salivary production
Saliva production will be measured by having participants chew inert gum base to the pace of a metronome (70 beats per minute) while expectorating saliva (without swallowing) into the saliva collection aid for 5 minutes total40. Cryovials will be weighed before and after collection and the difference in weight (g) will represent the amount of saliva produced in 5 minutes for each condition.
Shear wave velocity with acoustic radiation force impulse
Assess imaging characteristics of submandibular glands after MSC, measured by ultrasound
Full Information
NCT ID
NCT05820711
First Posted
April 6, 2023
Last Updated
October 17, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT05820711
Brief Title
Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
Official Title
A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
November 2027 (Anticipated)
Study Completion Date
November 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this clinical research study is to evaluate the safety and tolerability of injecting certain cells that you produce in your bone marrow called mesenchymal stem cells (MSCs) into your salivary glands.
Participants will have head and neck cancer that was treated with radiation therapy, and in this study will:
Undergo a collection of bone marrow using a needle;
Donate saliva;
Undergo a salivary gland ultrasound; and,
Complete questionnaires that ask about dry mouth
Participants can expect to be in this study for up to 30 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Xerostomia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal Stem Cell (MSC) injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MSC
Intervention Description
Injection of MSCs into submandibular glands at pre-specified dose level:
Dose -1: 5 (4 - 6) x10^6 MSCs (to be used only if Dose level 1 is not tolerated) per gland (0.5 ml)
Dose 0: 10 (8 - 12) x10^6 MSCs per gland (1 ml)
Dose 1: 20 (16 - 24) x10^6 MSCs per gland (2 ml)
Primary Outcome Measure Information:
Title
Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)
Description
RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT)
Time Frame
Up to 1 month post-injection
Title
Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale
Description
Incidence of pain assessed as greater than 5 on standard 0-10 point pain scale (0=not at all to 10=worst pain imaginable)
Time Frame
1 month post-injection
Title
Safety and Tolerability: Number of Serious Adverse Events
Description
Incidence of any serious adverse event
Time Frame
Up to 1 month post-injection
Title
Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events
Description
Incidence of pre-specified adverse events
Time Frame
Up to 1 month post-injection
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
Efficacy of MSC assessed through University of Michigan Xerostomia Related Quality of Life (XeQOL) scale, which is a 15-item assessment scale with 4 domains. The score is the average of all responses of all domains and can range from 0 to 4, where higher scores indicate increased xerostomia burden.
Time Frame
Baseline to 24 months post-injection
Title
Change in Quality of Life
Description
Efficacy of MSC assessed through the MD Anderson Dysphagia Index (MDADI), which is a 20-item questionnaire designed for evaluating the impact of dysphagia (swallowing ability). Scores range from 20 (extremely low functioning) to 100 (high functioning).
Time Frame
Baseline to 24 months post-injection
Title
Change in Quality of Life
Description
Efficacy of MSC assessed through VAS xerostomia questionnaire, which is an 8-item questionnaire that measures the perception of dry mouth. Scores range from 0-10, with 0 being low dryness and 10 being high dryness.
Time Frame
Baseline to 24 months post-injection
Title
Change in salivary production
Description
Saliva production will be measured by having participants chew inert gum base to the pace of a metronome (70 beats per minute) while expectorating saliva (without swallowing) into the saliva collection aid for 5 minutes total40. Cryovials will be weighed before and after collection and the difference in weight (g) will represent the amount of saliva produced in 5 minutes for each condition.
Time Frame
Baseline to 24 months post-injection
Title
Shear wave velocity with acoustic radiation force impulse
Description
Assess imaging characteristics of submandibular glands after MSC, measured by ultrasound
Time Frame
3, 6, and 12 months post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of histological diagnosis of head and neck cancer (HNC) that was treated with radiation therapy and currently clinically or radiologically no evidence of disease (NED)
Xerostomia, defined as patient reported salivary function (pre-treatment) ≤ 80% of healthy (pre-radiation)
≥ 18 years of age, ≤ 90 years of age.
Patients ≥ 2 years from completion of radiation therapy for HNC
Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
Willing and able to give informed consent
Radiographically confirmed submandibular gland(s)
Exclusion Criteria:
Salivary gland disease (i.e., sialolithiasis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer Connect
Phone
800-622-8922
Email
clinicaltrials@cancer.wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Kimple, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques Galipeau, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Director
Facility Information:
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Connect
Phone
800-622-8922
Email
clinicaltrials@cancer.wisc.edu
First Name & Middle Initial & Last Name & Degree
Randall Kimple, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
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