Trial Outcomes & Findings for Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer (NCT NCT02331134)
NCT ID: NCT02331134
Last Updated: 2025-05-31
Results Overview
Tissue and hematopoietic/mesenchymal stem cell will be collected from patients with melanoma and squamous head and neck cancer. These will be used to establish humanized animal model.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
Baseline
Results posted on
2025-05-31
Participant Flow
Participant milestones
| Measure |
Melanoma, Head and Neck
10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days
Filgrastim: Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Melanoma, Head and Neck
10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days
Filgrastim: Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Melanoma, Head and Neck
n=8 Participants
10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days
Filgrastim: Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 16.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: BaselineTissue and hematopoietic/mesenchymal stem cell will be collected from patients with melanoma and squamous head and neck cancer. These will be used to establish humanized animal model.
Outcome measures
| Measure |
Melanoma, Head and Neck
n=8 Participants
10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days
Filgrastim: Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule
|
|---|---|
|
Tissue and Hematopoietic Stem Cell Collection
|
8 Participants
|
Adverse Events
Melanoma, Head and Neck
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Melanoma, Head and Neck
n=8 participants at risk
10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days
Filgrastim: Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule
|
|---|---|
|
General disorders
Cancer Cachexia
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Cardiac disorders
Left Descending Coronary Artery Stenosis
|
12.5%
1/8 • Number of events 1 • 42 days
|
Other adverse events
| Measure |
Melanoma, Head and Neck
n=8 participants at risk
10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days
Filgrastim: Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule
|
|---|---|
|
Skin and subcutaneous tissue disorders
Acneform rash
|
12.5%
1/8 • Number of events 2 • 42 days
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Immune system disorders
Arthralgia
|
37.5%
3/8 • Number of events 3 • 42 days
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Cardiac disorders
Atrial Flutter
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
General disorders
Pain
|
37.5%
3/8 • Number of events 5 • 42 days
|
|
General disorders
Cachexia
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Infections and infestations
Chills
|
25.0%
2/8 • Number of events 2 • 42 days
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
25.0%
2/8 • Number of events 2 • 42 days
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • 42 days
|
|
Psychiatric disorders
Dysphagia
|
12.5%
1/8 • Number of events 2 • 42 days
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
General disorders
Fatigue
|
37.5%
3/8 • Number of events 3 • 42 days
|
|
Gastrointestinal disorders
Generalized aches
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Renal and urinary disorders
Glucosuria
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
General disorders
Headache
|
25.0%
2/8 • Number of events 2 • 42 days
|
|
Vascular disorders
Hematoma
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
General disorders
Hot flashes
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Metabolism and nutrition disorders
hyponatremia
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • Number of events 2 • 42 days
|
|
Vascular disorders
Lymphedema
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • Number of events 2 • 42 days
|
|
Nervous system disorders
Neuropathy
|
25.0%
2/8 • Number of events 2 • 42 days
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
General disorders
Sore throat
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Infections and infestations
Stomatitis
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • Number of events 1 • 42 days
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • 42 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place