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

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.

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.