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

Primary Purpose

Malignant Melanoma, Head and Neck Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Filgrastim

About this trial

This is an interventional basic science trial for Malignant Melanoma focused on measuring Tissue, Hematopoietic Stem Cell, Melanoma, Squamous Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
Clinically significant and active malignancy other than incurable melanoma or head and neck squamous cell cancer.
Known hepatitis B or C, or HIV.

Sites / Locations

University of Colorado Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Melanoma, head and neck

Arm Description

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

Outcomes

Primary Outcome Measures

Tissue and Hematopoietic Stem Cell 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

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

Full Information

NCT ID

NCT02331134

First Posted

December 26, 2014

Last Updated

June 12, 2023

Sponsor

University of Colorado, Denver

Collaborators

Karsh Family Research Fund

1. Study Identification

Unique Protocol Identification Number

NCT02331134

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 13, 2015 (Actual)

Primary Completion Date

July 6, 2018 (Actual)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

Karsh Family Research Fund

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Melanoma, Head and Neck Cancer

Keywords

Tissue, Hematopoietic Stem Cell, Melanoma, Squamous Head and Neck Cancer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Melanoma, head and neck

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Filgrastim

Other Intervention Name(s)

Neupogen

Intervention Description

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

Primary Outcome Measure Information:

Title

Tissue and Hematopoietic Stem Cell Collection

Description

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.

Time Frame

At the time of sample collection

Secondary Outcome Measure Information:

Title

Identify pharmacodynamic markers

Description

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Jimeno, MD, PhD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Cancer Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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