Clinical trial · Interventional
Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer
Pilot Study of Tissue and Hematopoietic/Mesenchymal Stem Cell Collection for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer
NCT02331134CI-TRIAL-00090413completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Filgrastim | Drug | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Melanoma, head and neck
- description
- 10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days
- interventionNames
- Drug: Filgrastim
Primary outcomes (1)
- measure
- Tissue and Hematopoietic Stem Cell Collection
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy proven incurable melanoma or incurable HNSCC amenable to have biopsy and/or surgical resection of either the primary and/or locoregional metastatic site, at the University of Colorado Hospital. 2. Age ≥ 21 years old per NCI/NIH guidelines 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0. 1, or 2 4. Adequate bone marrow, hepatic and renal function: * Absolute neutrophil count ≥ 1,500/µL. * Platelets ≥ 100,000/µL. * Hemoglobin ≥ 9.0 g/dL. * Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min. * Total bilirubin ≤ 1.5x ULN. * Aspartate Aminotransferase (AST)/Alanine Aminotransferase ( ALT) ≤ 2x ULN. 5. Measurable disease according to Response Criteria in Solid Tumors (RECIST) version 1.1. 6. O2 saturation ≥= 93% at room air. 7. Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: 1. Contraindication (absolute or relative) to granulocyte colony-stimulating factor (G-CSF) filgrastim usage: * known hypersensitivity to E coli-derived proteins' filgrastim, or any other component of the product. * Sickle cell disorders. * Clinically significant and active lung hemorrhagic or inflammatory disease, including but not limited to chronic obstructive pulmonary disease (COPD), autoimmune disease, and alveolar hemorrhage; or hypoxemia of any etiology requiring oxygen. * Clinically significant splenomegaly or splenic metastases; history of splenic rupture, recent splenic trauma or other clinically significant splenic disease that increases the risk of splenic rupture. 2. Clinically significant and active malignancy other than incurable melanoma or head and neck squamous cell cancer. 3. Known hepatitis B or C, or HIV.
References
Publications (0)
Data not yet available
No reference posted for this study.