Patients with metastatic melanoma receiving systemic therapy with checkpoint inhibitors

Patients with metastatic melanoma receiving systemic therapy with kinase inhibitors

Metastatic Melanoma

Dept. of Dermatology; Univeristy Hospital Regensburg

Immune Monitoring in Metastatic Melanoma

Immune Monitoring During Systemic Therapy of Metastatic Malignant Melanoma

As part of the course of therapy during routine check-up, blood samples are collected and then analyzed by flow cytometry (ONE study panel). Frequency of surface antigens of PBMC are analyzed and the characterized sub-populations are monitored during the follow-up. Thereby, changes in frequency of surface antigens will be assessed compared to baseline (before start of treatment). This allows to determine the individual immunophenotype of a patient.

As part of the course of therapy during routine check-up, blood samples are collected and then analyzed by flow cytometry (ONE study panel). Expression level of surface antigens of PBMC are analyzed and the characterized sub-populations are monitored during the follow-up. Thereby, changes in expression level of surface antigens will be assessed compared to baseline (before start of treatment). This allows to determine the individual immunophenotype of a patient.

Screening for liver inflammation (serum ALT U/l)

Screening for liver inflammation (serum AST U/l)

Edward Geissler

Head of Experimental Surgery

University of Regensburg

Stress

Cognitive Impairment

Burnout Syndrome

This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol

MBHP-Educa

Long-term meditation

This intervention is a lecture about neuroscience for education which the individuals will practice in their daily life in schools.

Cognitive stimulation

Centro Mente Aberta de Mindfulness e Promoção de Saúde

Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa).

Development and Implementation of Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa): Evaluation of Cognitive Functions and Epigenetic Modifications.

To evaluate quality of life through five subscales:
physical domain - mean of responses psychological domain - mean of responses relationships domain - mean of responses environment domain - mean of responses quality of life and perception of life - mean of responses
*each question response range one to five points Higher scores - Better Quality of Life

To evaluate the burnout clinical subtypes through three subscales:
Overload - mean, standard deviation and median Lack of development - mean, standard deviation and median Neglect - mean, standard deviation and median
*each question response range one to seven points
Higher scores - More Symptons of Burnout

To evaluate the Sleep Quality - sum of responses score
*each questions have a specific conversion to range zero to six
Higher scores - better sleep quality

To evaluate anxiety and depression symptoms through two subscales:
anxiety - sum depression - sum
each question range zero to four
higher score - more symptons

To evaluate the mindfulness trace through five subscales:
OBSERVING - mean DESCRIBING - mean NONJUDGE - mean NONREACT - mean ATC WITH AWARENESS - mean
each question range one to five
higher score - more mindful

To evaluate Self-Compassion level through five subscales:
self-judgment - mean and standard deviation over-identification - mean and standard deviation common humanity, isolation - mean and standard deviation self-kindness - mean and standard deviation mindfulness - mean and standard deviation
each question range one to five
higher score - more self compassion

To evaluate positive and negative Affect through two subscales:
positive affect - sum negative affect - sum
each question range one to five
higher score - more frequent

To evaluate person's circadian rhythm (biological clock) (sum of all responses)

To evaluate the IL-6, IL-10, TNF-α, RIPK2, COX2 biomarkers
*Concentration in micromol per liter. (mean and standard deviation, median and quartile per groups)

To evaluate the HDAC (2, 3 e 9)
*Relative Expression. (mean and standard deviation, median and quartile per groups)

To evaluate memory (number of word remember)

To evaluate attention (time to trail every letter or/and number)

To evaluate attention and inhibitory behavior (number of errors and time)

Marcelo Demarzo, MD, PhD

Principal Investigator

Drugs: Gemcitabine - 21 day cycle. 9-ING-41

Drugs: Nab-paclitaxel. Gemcitabine - 28 day cycle. 9-ING-41.

Drugs: Paclitaxel. Carboplatin. 9-ING-41.

Cancer

Lymphoma

Pancreatic Cancer

Glioblastoma Multiforme

Sarcoma

Breast Cancer

Bladder Cancer

Renal Cancer

Ovarian Cancer

Refractory Cancer

Refractory Neoplasm

Refractory Non-Hodgkin Lymphoma

Refractory Brain Tumor

Pancreatic Adenocarcinoma

Resistant Cancer

Neoplasm Metastasis

Neoplasm of Bone

Neoplasm, Breast

Neoplasm of Lung

Neoplasms,Colorectal

Neoplasms Pancreatic

Malignant Glioma

Malignancies

Malignancies Multiple

Bone Metastases

Bone Neoplasm

Bone Cancer

Pancreas Cancer

Pancreatic Neoplasms

Breast Neoplasms

Starting dose of-9-ING-41 will be administered on Day 1 and 4 each week of a 21-day cycle. 9-ING-41 will be administered intravenously over 60 minutes.

9-ING-41

Gemcitabine 1250 mg/m2 as a 30-minute intravenous infusion on Days 1 and 8 of a 21-day cycle

Gemcitabine - 21 day cycle

Doxorubicin 75 mg/m2, intravenous bolus on Day 1 of a 21-day cycle up to a maximum lifetime dose of 550 mg/m2.

Doxorubicin.

Lomustine 30 mg/m² orally as a single dose, weekly for twelve weeks.

Lomustine

Carboplatin AUC 6 IV over 1 hour on Day 1 of a 21-day cycle.

Carboplatin.

Nab-paclitaxel 125 mg/m2 intravenously on Days 1, 8 and 15 of a 28-day cycle

Nab paclitaxel.

Paclitaxel 175 mg/m2 intravenously over 3 hours on Day 1 of a 21-day cycle.

Paclitaxel.

Gemcitabine 1000 mg/m2 intravenously over 30-minutes on Days 1, 8 and 15 of a 28-day cycle

Gemcitabine - 28 day cycle

Irinotecan 350 mg/m2 intravenously over 90-minutes on Day 1 of a 21-day cycle

Irinotecan

UCSF Helen Diller Family Comprehensive Cancer Center

Miami Cancer Institute

Moffitt Cancer Center

Winship Cancer Institute

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Kansas University Cancer Center

University of Michigan

Mayo Clinic

Rhode Island Hospital

Sanford Research

Vanderbilt-Ingram Cancer Center

Fred Hutchinson Cancer Research Center

Netherlands Cancer Institute

9-ING-41 in Patients With Advanced Cancers

Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined With Chemotherapy, in Patients With Refractory Hematologic Malignancies or Solid Tumors

The standard assessments used to assign a score to any affected organ system as per the NCI CTCAE 4.03 will be conduced at each protocol-specified timepoint.

threonine/necrosis

Immune Monitoring in Metastatic Melanoma

Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa).

9-ING-41 in Patients With Advanced Cancers

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