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

NCT02331134 | Completed Results DMC

• 2 other identifiers: 14-0842.ccNCI-2015-00479
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Melanoma; Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (1)

Melanoma, head and neck

OTHER

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

Drug: Filgrastim

Interventions

Filgrastim DRUG

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

Also known as: Neupogen

Melanoma, head and neck

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Karsh Family Research Fund: collaborator

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Melanoma; Head and Neck Neoplasms

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Antonio Jimeno, MD, PhD
• Organization: University of Colorado Hospital

antonio.jimeno@cuanschutz.edu

3037242478

Study Officials

• Antonio Jimeno, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2014
• First Posted: January 6, 2015
• Study Start: May 13, 2015
• Primary Completion: July 6, 2018
• Study Completion: March 6, 2025
• Last Updated: May 31, 2025
• Results First Posted: October 31, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)