Stem Cell Research for Melanoma and Head and Neck Cancer

Overseen By Cole Sprague

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: G-CSF

Disqualifiers: Sickle cell, COPD, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 week

9 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Antonio Jimeno, MD, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adults over 21 with incurable melanoma or head and neck squamous cell cancer (HNSCC) that can be biopsied. Participants must have a performance status of 0-2, meaning they are fully active to limited in physical activity but able to care for themselves. They need normal bone marrow, liver, and kidney function, measurable disease by certain criteria, and good oxygen levels without assistance.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

Your blood, liver, and kidney functions are at normal levels. You have enough red and white blood cells, and your organs are working well. You have measurable disease according to specific criteria, and you can understand and agree to sign a consent form.

I have melanoma or head/neck cancer that cannot be cured, but can be biopsied or surgically removed at the University of Colorado Hospital.

Exclusion Criteria

I don't have allergies to E. coli proteins, sickle cell, severe lung disease, significant spleen issues, active cancer other than melanoma or head/neck cancer, or hepatitis B/C or HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Collection

Collection of peripheral hematopoietic stem cells, blood, and tumor tissue from patients

1 week

1 visit (in-person)

Treatment

Participants receive 10 μg/kg/day of Filgrastim subcutaneously for 4 days

1 week

4 visits (in-person)

Follow-up

Participants are monitored for pharmacodynamic markers and efficacy of therapies

Up to 6 months

Treatment Details

Interventions

• Filgrastim

Trial Overview The study is testing the use of Filgrastim—a medication that promotes white blood cell growth—to develop a pre-clinical model for melanoma and HNSCC. This will help understand these cancers better and find more personalized treatments.

Participant Groups

Group I: Melanoma, head and neck Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Karsh Family Research Fund

Collaborator

Trials

1

Recruited

9+

Karsh Family Research Fund

Collaborator

Trials

1

Recruited

9+