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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT02331134

Collaborator

Karsh Family Research Fund (Other)

Enrollment

Location

Arm

93.6

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Melanoma Head and Neck Cancer	Drug: Filgrastim	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 13, 2015

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Melanoma, head and neck 10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days	Drug: Filgrastim Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule Other Names: Neupogen

Arm

Intervention/Treatment

Other: Melanoma, head and neck

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

Drug: Filgrastim

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

Other Names:

Neupogen

Outcome Measures

Primary Outcome Measures

Tissue and Hematopoietic Stem Cell Collection [At the time of sample collection]
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.

Secondary Outcome Measures

Identify pharmacodynamic markers [Up to 6 months]
Patients receiving therapy with Food and Drug Administration (FDA) approved drugs of interest will be asked to provide sequential blood and tumor biopsies to study the molecular and immune events occurring as a result of therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.