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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02331134
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Antonio Jimeno, MD, PhD
Principal Investigator Affiliation	University of Colorado, Denver
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Melanoma, Head and Neck Cancer

Additional Details

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.

Arms & Interventions

Arms

Other: Melanoma, head and neck

10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days

Interventions

Drug: - Filgrastim

Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Colorado Cancer Center, Aurora, Colorado

Status

Recruiting

Address

University of Colorado Cancer Center

Aurora, Colorado, 80045

Site Contact

Meaghan Greb

meaghan.greb@cuanschutz.edu

303-848-0657

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