NCT02331134

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Melanoma
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Filgrastim	Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule

Timeline

• Start date: 2015-05-13
• Primary completion: 2018-07-06
• Completion: 2025-03-06
• First posted: 2015-01-06
• Last updated: 2025-05-31
• Results posted: 2023-10-31

Locations

1 site across 1 country: United States