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Stem Cell Research for Melanoma and Head and Neck Cancer

N/A
Waitlist Available
Led By Antonio Jimeno, MD, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new platform to learn more about melanoma and head and neck squamous cell cancer to develop better, more individualized treatments.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Filgrastim may cause side effects such as allergic reactions to E coli-derived proteins, spleen enlargement which could lead to rupture, lung problems like COPD or alveolar hemorrhage, or an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have melanoma or head/neck cancer that cannot be cured, but can be biopsied or surgically removed at the University of Colorado Hospital.
Select...
I am 21 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tissue and Hematopoietic Stem Cell Collection
Secondary study objectives
Identify Pharmacodynamic Markers

Side effects data

From 2014 Phase 3 trial • 118 Patients • NCT00003138
31%
Fatigue
23%
Pulmonary
15%
Infection
8%
Cardiac adverse event
8%
Diarrhea
8%
Esophagitis
8%
Hot flashes
8%
Other toxicities
8%
Hemorrhage
8%
Skin
8%
Weight loss
8%
Neuropathy-clinical
8%
Edema
8%
Anemia
8%
Neuropathy-psych
8%
Abdominal cramps
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erythropoietin (300 Units/kg) and Filgrastim (Step 4)
Supportive Care (Step 1)
Erythropoietin (Step 1)
Erythropoietin (Cross-over; Step 2)
Erythropoietin (150 Units/kg) and Filgrastim (Step 3)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Melanoma, head and neckExperimental Treatment1 Intervention
10 μg/kg/day of Filgrastim will be given subcutaneously for 4 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
2000
Completed Phase 3
~3690

Find a Location

Who is running the clinical trial?

Karsh Family Research FundUNKNOWN
University of Colorado, DenverLead Sponsor
1,804 Previous Clinical Trials
2,822,157 Total Patients Enrolled
10 Trials studying Melanoma
337 Patients Enrolled for Melanoma
Antonio Jimeno, MD, PhDPrincipal InvestigatorUniversity of Colorado, Denver
6 Previous Clinical Trials
304 Total Patients Enrolled

Media Library

Melanoma, head and neck Clinical Trial Eligibility Overview. Trial Name: NCT02331134 — N/A
Melanoma Research Study Groups: Melanoma, head and neck
Melanoma Clinical Trial 2023: Melanoma, head and neck Highlights & Side Effects. Trial Name: NCT02331134 — N/A
Melanoma, head and neck 2023 Treatment Timeline for Medical Study. Trial Name: NCT02331134 — N/A
~1 spots leftby Nov 2025
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