Malignant MelanomaNCT02331134
Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer
A study testing Filgrastim in people with Malignant Melanoma and Head and Neck Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Head and Neck Cancer
- What is being tested?
- Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2015to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
Official title: Pilot Study of Tissue and Hematopoietic/Mesenchymal Stem Cell Collection for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer
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.
Read the 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
- Being tested
- Filgrastim
- Keywords
- Tissue, Hematopoietic Stem Cell, Melanoma, Squamous Head and Neck Cancer
- Medical subject headings
- Melanoma, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Also called Neupogen
Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule
| Study group | Role | What they receive |
|---|---|---|
| Melanoma, head and neck | Other | 10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days Receives: Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study start13 May 2015
- Primary completion6 Jul 2018
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Karsh Family Research Fund
- Responsible party
- Sponsor
- Investigators
- Antonio Jimeno, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331134
- Sponsor's protocol ID
- 14-0842.cc
- Other IDs
- NCI-2015-00479
- Status last verified
- May 2025
- First submitted
- 26 Dec 2014
- Last updated
- 31 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Tissue and Hematopoietic/Mesenchymal Stem Cell Collection for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02331134
- Acronym / sponsor ID
- 14-0842.cc
- Conditions
- Malignant Melanoma, Head and Neck Cancer
- Keywords
- Tissue, Hematopoietic Stem Cell, Melanoma, Squamous Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Karsh Family Research Fund
- Study start
- 13 May 2015 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Posted 31 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma, head and neck | Other | Drug: Filgrastim10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Measurable disease according to Response Criteria in Solid Tumors (RECIST) version 1.1.
Key exclusion criteria (7 listed)
- Contraindication (absolute or relative) to granulocyte colony-stimulating factor (G-CSF) filgrastim usage:
- Clinically significant and active malignancy other than incurable melanoma or head and neck squamous cell cancer.
- Known hepatitis B or C, or HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgrastimAlso: NeupogenPatients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule | Drug | Melanoma, head and neck |
Primary outcome
Tissue and Hematopoietic Stem Cell Collection
Time frame: Baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Jimeno, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filgrastim in people with Malignant Melanoma and Head and Neck Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue and Hematopoietic Stem Cell Collection (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.