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Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer
NA trial testing Filgrastim in Malignant Melanoma in 9 participants. Completed in 6 March 2025.
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 9 |
| Start date | 13 May 2015 |
| Primary completion | 6 July 2018 |
| Estimated completion | 6 March 2025 |
| Sites | 1 location across United States |
University of Colorado, Denver
18 and older, any sex, with Malignant Melanoma or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Melanoma, Head and Neck | 8 |
Time frame: 42 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Melanoma, Head and Neck |
|---|---|---|
| Cancer Cachexia | General disorders | — |
| Left Descending Coronary Artery Stenosis | Cardiac disorders | — |
| Reaction | System | Melanoma, Head and Neck |
|---|---|---|
| Arthralgia | Immune system disorders | — |
| Pain | General disorders | — |
| Fatigue | General disorders | — |
| Chills | Infections and infestations | — |
| Congestion | Respiratory, thoracic and mediastinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Headache | General disorders | — |
| Insomnia | Psychiatric disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Neuropathy | Nervous system disorders | — |
| Acneform rash | Skin and subcutaneous tissue disorders | — |
| Anxiety | Psychiatric disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Atrial Flutter | Cardiac disorders | — |
| Cachexia | General disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Dysphagia | Psychiatric disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Generalized aches | Gastrointestinal disorders | — |
| Glucosuria | Renal and urinary disorders | — |
| Hematoma | Vascular disorders | — |
| Hot flashes | General disorders | — |
| Hyperlipidemia | Metabolism and nutrition disorders | — |
| Hypertension | Vascular disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| hyponatremia | Metabolism and nutrition disorders | — |
| Lymphedema | Vascular disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | — |
| Sore throat | General disorders | — |
| Stomatitis | Infections and infestations | — |
| Tachycardia | Cardiac disorders | — |
| Vomiting | Gastrointestinal disorders | — |
Most-reported serious reactions: Cancer Cachexia, Left Descending Coronary Artery Stenosis.
Data from ClinicalTrials.gov NCT02331134 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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