Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer

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• 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.
• Clinically significant and active malignancy other than incurable melanoma or head and neck squamous cell cancer.
• Known hepatitis B or C, or HIV.

• 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.
• Age ≥ 21 years old per NCI/NIH guidelines
• Eastern Cooperative Oncology Group (ECOG) performance status of 0. 1, or 2
• 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.
• Measurable disease according to Response Criteria in Solid Tumors (RECIST) version 1.1.
• O2 saturation ≥= 93% at room air.
• Ability to understand and willingness to sign a written informed consent document