An interventional study of Filgrastim in Malignant Melanoma and Head and Neck Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Basic science
The overall goal of this study is to develop a pre-clinical platform of melanoma and head and neck squamous cell cancer that will allow the investigators to learn more about these diseases and discover better and more individualized treatments.
The main objective of this study is to establish a humanized animal model. Investigators will consent patients who have melanoma and head and neck squamous cell cancer (HNSCC) and agree to take part in this research study. They will obtain peripheral hematopoietic stem cells (HSC), blood and tumor tissue at baseline from blood and tumor samples from these patients for use in establishing tumor explants in humanized mice. Therapy results on humanized mice will be correlated with existing or newly acquired efficacy results from those same immune-based or other therapies in patients. A secondary objective is to identify pharmacodynamic markers associated with each drug and biomarkers for evidence of efficacy or lack of thereof. Where possible, subjects receiving therapy with FDA-approved drugs of interest will be asked to provide sequential blood and tumor biopsies to study the molecular and immune events that may occur as a result of drug therapy.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 9 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate bone marrow, hepatic and renal function:
Exclusion Criteria:
Contraindication (absolute or relative) to granulocyte colony-stimulating factor (G-CSF) filgrastim usage:
10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days
Drug: Filgrastim
Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule
Also known as: Neupogen
Tissue and Hematopoietic Stem Cell Collection
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.
Time frame: Baseline
| Milestone | Melanoma, Head and Neck |
|---|---|
| Started | 9 |
| Completed | 8 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Participants | Melanoma, Head and Neck |
|---|---|
| Tissue and Hematopoietic Stem Cell Collection | 8 |
Collected over 42 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Melanoma, Head and Neck | 0/8 (0%) | 2/8 (25%) | 8/8 (100%) |
| Event | Melanoma, Head and Neck |
|---|---|
| Cancer CachexiaGeneral disorders | 1/8 |
| Left Descending Coronary Artery StenosisCardiac disorders | 1/8 |
| Event | Melanoma, Head and Neck |
|---|---|
| ArthralgiaImmune system disorders | 3/8 |
| PainGeneral disorders | 3/8 |
| FatigueGeneral disorders | 3/8 |
| ChillsInfections and infestations | 2/8 |
| CongestionRespiratory, thoracic and mediastinal disorders | 2/8 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/8 |
| HeadacheGeneral disorders | 2/8 |
| InsomniaPsychiatric disorders | 2/8 |
| MyalgiaMusculoskeletal and connective tissue disorders | 2/8 |
| NeuropathyNervous system disorders | 2/8 |
| Age, Categorical(Participants) | Melanoma, Head and Neck |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 1 |
| Age, Continuous(years) | Melanoma, Head and Neck |
|---|---|
| Mean | 49.1 ± 16.9 |
| Sex: Female, Male(Participants) | Melanoma, Head and Neck |
|---|---|
| Female | 4 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Melanoma, Head and Neck |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Melanoma, Head and Neck |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Melanoma, Head and Neck |
|---|---|
| United States | 8 |
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Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver