Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Patients with squamous cell carcinoma of the head and neck, targeted therapies, plasma samples:

* Group 1 = patients treated with radiation therapy and cetuximab according to Bonner et al \[11\]
* Group 2 = patients treated with cetuximab in combination with chemotherapy according to Vermorken et al. \[10\]
* Group 3 = patients treated with a molecular targeted agent as a part of a clinical study

Plasma samples at baseline (and one whole blood sample) and at every radiological evaluations

Plasma samples

Jean-Pascal Machiels, MD, PhD

Séverine Carlier, MD

Renaud Poncin, MD

Dora Barrientos, Nurse

Christophe Lonchay, MD

Janique Dewelle, Bio MSc

Emmanuel Seront, MD, PhD

Isabelle Buelens, Study Co

Maude Piron, PhD

Brieu Sautois

Stéphanie Henry, MD

Monique Gilsoul, Study Co

The investigators will collect plasma samples at baseline, during treatment, and at progression.

In this study, the investigators will collect plasma samples at baseline, during treatment, and at progression. This plasma bank will be used to study the potential value of some biomarkers to predict treatment activity or resistance to cetuximab or other targeted agents

One EDTA tube is collected at the beginning of the study and there are only plasma samples at baseline, during treatment, and at progression.

Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients

Prospective Collection of Plasma Samples From Patients Treated With Molecular Targeted Therapies for Squamous Cell Carcinoma of the Head and Neck

All the analyses will be done when we have enough of collected samples

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Exercise treatment will consist of individualized walking delivered up to 5 times weekly. Patients in all cohorts will receive one dose of exercise (i.e., \~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service

Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate one dose of exercise (i.e., \~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service

exercise (walking)

Plasma samples will be obtained at baseline.

plasma samples

blood draw

Lee Jones, PhD

Jessica Scott, PhD

Paul C Boutros, PhD

Paul Boutros, PhD

Suzanne Carlisle

Jason Locasale, PhD

This study is being done to answer the following question: Will aerobic exercise (exercise that stimulates and strengthens the heart and lungs, and improves the body's use of oxygen) change the biomarkers (signs of disease) found in the blood?

For cohort 3 only. Men with histologically-confirmed localized prostate cancer undergoing active surveillance. Both patients and investigators will be fully blinded to the ctDNA status of patients during study participation.

Researching the Effect of Aerobic Exercise on Cancer

Exercise as Interception Therapy: A "Proof-of-Concept" Digitized Trail

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

measured by targeted CH panel in peripheral blood

measured by the amount of circulating tumor DNA (ctDNA)

Memorial Sloan Kettering Cancer Center

Immunomodulating Agents

Immunologic Factors

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.

Immunotherapeutic Agent

Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

Molecular Target

The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy.

Immunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

With the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer.

The trial will include patients with any type of cancer treated with one of the following regimens after signing of the patient's informed consent:

* I: Molecular targeted agent
* II: Immunotherapy

Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy

Efficacy will be determined in terms of overall responses according to standard practice by the local investigator. Disease and response assessments are defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Overall survival is defined as the time from the date of inclusion to the date of death from any cause or to the date of last follow-up (in exceptional cases where it is impossible to document the date of death). Every effort should be made to document the cause of death.

Progression free survival (PFS) will be measured from the date of inclusion to the date of progression or death, whatever the cause.

Progression will be defined according to the RECIST criteria.

Objective tumor response will be measured according to the RECIST 1.1 criteria.

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Aggression

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Antirheumatic Agents

Anti-Inflammatory Agents

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

Immunoglobulins

Alemtuzumab

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

For all patients enrolled, the study will begin with a stepped-up schedule of single agent Alemtuzumab given subcutaneously (SQ) on week #1. Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1. If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5. Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose

CHOP will be given 60-120 minutes following SQ administration of Alemtuzumab as follows: cyclophosphamide 750 mg/m2 IV on day 1, doxorubicin 50 mg/m2 IV on day 1, vincristine 1.4 mg/m2 (maximum dose = 2 mg) IV on day 1, and prednisone 100 mg PO on days 1-5.

CHOP

Single agent Alemtuzumab given subcutaneously (SQ) on week #1. Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1. If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5.

Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose.

Plasma Samples

Pierluigi Porcu, MD

Purpose: This study will evaluate the safety of CHOP plus Alemtuzumab in patients with T/NK cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous treatments. The biological response of lymphoma cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration.

Rationale: The drug combination called CHOP, or Cyclophosphamide (Cytoxan), Doxorubicin (Adriamycin), Vincristine (Oncovin), and Prednisone (Deltasone), has been used against different types of lymphoma for many years. Researchers are investigating what other therapies to combine with the CHOP regimen to improve outcomes for patients with lymphoma. The current study combines CHOP with alemtuzumab, a monoclonal antibody used against leukemia. Monoclonal antibodies are a type of immunotherapy used against some types of cancer. They are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins. Alemtuzumab is designed to target leukemia cells that express a specific protein. The specific protein recognized by alemtuzumab is the CD52 antigen. This antigen, or substance that causes the immune system to create a specific response, is expressed on normal B and T cells, as well as on abnormal T cells characteristic of certain cancers. Alemtuzumab causes the CD52 antigen to bind with B-cell lymphocytes. This study will also assess the theory that alemtuzumab may increase the effectiveness of the chemotherapy agents included in the CHOP regimen.

Treatment: Patients in this study will receive alemtuzumab and CHOP. Alemtuzumab will be given through injections into the skin and CHOP will be administered through intravenous infusions. Patients will receive alemtuzumab alone during the first week of the study. An increasing amount of alemtuzumab will be given during the first week. If patients cannot tolerate the highest amount of alemtuzumab determined as appropriate within one week, they will be removed from the study. Once the highest dose of alemtuzumab has been achieved, patients will then receive both alemtuzumab and CHOP every three weeks. This schedule will be repeated up to eight times. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients	NCT02139020	Squamous Cell C...	Plasma samples	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Researching the Effect of Aerobic Exercise on Cancer	NCT03996239	Cancer	exercise (walki... plasma samples blood draw	18 Years -	Memorial Sloan Kettering Cancer Center
Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy	NCT03835520	Cancer	Immunotherapeut... Molecular Targe...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Researching the Effect of Aerobic Exercise on Cancer	NCT03996239	Cancer	exercise (walki... plasma samples blood draw	18 Years -	Memorial Sloan Kettering Cancer Center
CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas	NCT00323323	Non-Hodgkin's L...	CHOP Alemtuzumab Plasma Samples	18 Years -	Ohio State University Comprehensive Cancer Center
Researching the Effect of Aerobic Exercise on Cancer	NCT03996239	Cancer	exercise (walki... plasma samples blood draw	18 Years -	Memorial Sloan Kettering Cancer Center

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