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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about melanoma and head and neck cancer to discover better, personalized treatments. Participants will receive Filgrastim, a medication that boosts white blood cells, to study its effects on these cancers. Suitable candidates have incurable melanoma or head and neck cancer and can undergo biopsies or surgery at the University of Colorado Hospital. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to more effective treatments for these cancers.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Filgrastim is likely to be safe for humans?

Research has shown that filgrastim is generally safe for people. Studies have found that filgrastim effectively prevents febrile neutropenia, a condition where white blood cell counts drop, often due to chemotherapy. In these studies, participants tolerated filgrastim well, with side effects similar to those of other versions of the drug, making them predictable and manageable.

Additionally, research on a filgrastim biosimilar (a nearly identical copy) demonstrated similar safety results to the original filgrastim, indicating consistent safety across different versions.

Although specific data on using filgrastim for head and neck cancer is limited, its approval for other uses suggests it is safe. Participants can feel confident that filgrastim has been widely studied and is considered safe in various situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for melanoma and head and neck cancer, which often include surgery, radiation, and chemotherapy, Filgrastim offers a unique approach by leveraging its ability to stimulate the production of white blood cells. Researchers are excited about Filgrastim because it is a growth factor that encourages the bone marrow to produce more neutrophils, a type of white blood cell critical for fighting infections and potentially strengthening the body's immune response against cancer cells. Additionally, Filgrastim is administered subcutaneously, which is less invasive and might improve patient compliance compared to some existing treatments. This novel mechanism and delivery method make Filgrastim an exciting potential addition to cancer treatment strategies.

What evidence suggests that Filgrastim might be an effective treatment for melanoma and head and neck cancer?

Research has shown that filgrastim helps prevent neutropenia, a condition characterized by a low count of certain white blood cells, in patients undergoing chemotherapy. It has proven safe and effective in managing side effects like painful mouth sores in patients with head and neck cancer. Studies have found that filgrastim significantly reduces the risk of febrile neutropenia, a serious condition involving fever and low white blood cell counts. In this trial, participants with melanoma and head and neck cancer will receive filgrastim to explore its potential benefits in boosting white blood cell production, which might enhance cancer treatment. ^{2 5 6 7 8}

Who Is on the Research Team?

Antonio Jimeno, MD, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9712837/

Effectiveness and Safety of Filgrastim (Neupogen™) ... Filgrastim and filgrastim-aafi had comparable effectiveness and safety as primary prophylaxis for chemotherapy-induced febrile neutropenia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11730191/

Safety and efficacy of mecapegfilgrastim in preventing ... Mecapegfilgrastim is effective in preventing neutropenia in patients with head and neck cancer undergoing chemotherapy and has an acceptable safety profile.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1043466623002958

Hematopoietic colony-stimulating factors in head and neck ... Filgrastim has been shown to be safe and effective ... Oral mucositis in head and neck cancer: evidence-based management and review of clinical trial data.

4. cancernetwork.com cancernetwork.com/view/primary-prophylaxis-with-biosimilar-of-filgrastim-appears-to-be-a-cost-effective-option-for-individuals-at-intermediate-risk-of-febrile-neutropenia

Primary Prophylaxis With Biosimilar of Filgrastim Appears ... A biosimilar of filgrastim-sndz has been identified as a cost-effective option for the treatment of patients who are undergoing curative ...

5. onclive.com onclive.com/view/fda-approves-second-filgrastim-biosimilar

FDA Approves Second Filgrastim Biosimilar In cycles 1 to 4 of treatment, 98.7% of patients receiving biosimilar filgrastim experienced treatment-emergent adverse events (TEAEs). Most ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8972123/

Phase 1 Clinical Trial Evaluating the Safety and Anti-Tumor ... ADP-0022-004 is a phase 1, dose-escalation trial to evaluate the safety and anti-tumor activity of ADP-A2M10 in three malignancies.

7. onclive.com onclive.com/view/biosimilar-filgrastim-safety-confirmed-in-analysis

Biosimilar Filgrastim Safety Confirmed in Analysis EP2006, a filgrastim biosimilar, produced safety results equivalent to those observed with referent filgrastim in a combined analysis of 2 phase ...

8. tcr.amegroups.org tcr.amegroups.org/article/view/94670/html

Safety and efficacy of mecapegfilgrastim in preventing ... However, data on its safety and efficacy in patients with head and neck cancer remain limited. This study aimed to evaluate the safety and ...