Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

tumor biopsy and blood draw during and after chemotherapy

tumor biopsy and blood draw

Mark E Burkard, MD, PhD

The purpose of this study is to determine if the investigators are able to locate and measure certain characteristics in breast cancer tumors that have been treated with paclitaxel that may correlate to how well the cancer will respond to the chemotherapy.

Feasibility Study of Biomarkers of Response to Neoadjuvant Paclitaxel in Locally Advanced Breast Cancer

National Cancer Institute (NCI)

University of Wisconsin, Madison

Nervous System Diseases

Rare Diseases

Glioma

Diffuse Intrinsic Pontine Glioma

Brain Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Stem Neoplasms

Infratentorial Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Gemcitabine

Antimetabolites

Gemcitabine will be given at 2100 mg/m2 IV over 30 minutes within 4 hours of planned surgical procedure. The surgical procedure is standard of care.

Participants receive a one time IV dose of gemcitabine prior to having standard of care surgery.

As part of standard of care, all participants will undergo tumor biopsy and collection of peripheral blood.

Tumor biopsy and blood draw

Carl Koschmann, M.D.

The primary aim of this study is to determine the presence of gemcitabine in childhood diffuse midline gliomas (DMG) (previously classified as diffuse intrinsic pontine glioma \[DIPG\]) after systemic treatment with the drug.

Participants in this study will be given a one-time, intravenous (IV) dose of gemcitabine prior to having standard-of-care surgery. During surgery, biopsies will be obtained for clinical and research purposes along with a blood sample. Cerebrospinal Fluid (CSF) is optional and will only be obtained if clinically indicated. This will be determined by the investigators and the provider performing the procedure.

Because patients will be undergoing a biopsy/resection as part of their standard-of-care therapy, this is an optimal time to obtain a tumor biopsy for this study. The biopsy will serve to see if the study drug is penetrating the tumor. Patients will then enter a follow-up period for 30 days post-surgery.

This trial is in conjunction with a University of Colorado trial started in 2016, "Gemcitabine in Children With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma" (NCT02992015).

Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma

An Early Phase 1 Trial of Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma

Gemcitabine will be considered to be detectable in a participant's tumor sample if gemcitabine or one of its metabolites (difluorodeoxyuridine \[dFdU\] or gemcitabine triphosphate \[dFdCTP\]) is detected at a measurable level in any of the participant's tumor samples. Undetectable gemcitabine will be defined as gemcitabine, dFdU, and dFdCTP levels below the detectable limits for all of an individual participant's samples, in the setting of detectable gemcitabine, dFdU, or dFdCTP in the plasma and/or cerebrospinal fluid (CSF) for that patient, and the pathologic review showing viable tumor tissue.

Gemcitabine, dFdU and dFdCTP will be quantified in the available tumor sample(s), in plasma, and in CSF (if available). For this pilot trial, gemcitabine PK results will be analyzed descriptively, and this trial is not designed for statistical analysis.

University of Colorado, Denver

University of Michigan Rogel Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study of Biomarkers of Response to Neoadjuvant Paclitaxel in Locally Advanced Breast Cancer	NCT01263613	Breast Cancer	tumor biopsy an...	18 Years -	University of Wisconsin, Madison
Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma	NCT04051047	Glial Tumor of ... Diffuse Intrins... Glioma	Gemcitabine Tumor biopsy an...	3 Years - 17 Years	University of Michigan Rogel Cancer Center
Feasibility Study of Biomarkers of Response to Neoadjuvant Paclitaxel in Locally Advanced Breast Cancer	NCT01263613	Breast Cancer	tumor biopsy an...	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for tumor biopsy and blood draw