NCT02331134Completed
Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer
Pilot Study of Tissue and Hematopoietic/Mesenchymal Stem Cell Collection for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 31 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 26 Dec 2014
- Start date
- 13 May 2015
- Primary completion date
- 6 Jul 2018
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Head and neck cancer, Melanoma
- NCT number
- NCT02331134
What you commit to
- Study type: Interventional
- Participants enrolled: 9
- From 13 May 2015 to the primary completion date, 6 Jul 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Cancer Center Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.