Head and Neck Cancer, Xerostomia
Conditions
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. There is no expanded access program available per this protocol.
Interventions
DRUGMSC
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)
Sponsors
University of Wisconsin, Madison
National Institute of Dental and Craniofacial Research (NIDCR)
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D) | Up to 1 month post-injection | 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 | 1 month post-injection | 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 | Up to 1 month post-injection | Incidence of any serious adverse event |
| Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events | Up to 1 month post-injection | Incidence of pre-specified adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Baseline to 24 months post-injection | 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 salivary production | Baseline to 24 months post-injection | 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 | 3, 6, and 12 months post-injection | Assess imaging characteristics of submandibular glands after MSC, measured by ultrasound |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGrace Blitzer, MD
University of Wisconsin, Madison
STUDY_DIRECTORJacques Galipeau, MD
University of Wisconsin, Madison
Outcome results
None listed