Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Cardiotoxicity

Sarcoma

Wilms Tumor

Neuroblastoma

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Neoplasms, Connective and Soft Tissue

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genetic Diseases, Inborn

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Soft Tissue Sarcoma

Acute Graft Versus Host Disease

Wilms' Tumor

Lymphosarcoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

blood sampling before, during and after doxorubicin administration

doxorubicin

Joachim Boos, MD, Prof.

Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity .

* Paediatric patients up to the age of 17 years will be included. Number and time points of PK sampling will depend on age and tumour type.
* PK samples will be collected from two doxorubicin administrations. Analyzing samples from two doxorubicin administrations will allow distinguishing between interindividual, intraindividual and residual variability.
* Doxorubicin and its major metabolite doxorubicinol will be measured in plasma using HPLC
* In addition, the natriuretic peptide BNP and the precursors NT-pro ANP and NT-proBNP as well as troponin T will be measured in plasma up to 28 days after doxorubicin administration to evaluate their use as clinical markers for cardiotoxicity.
* A data set of max 5 samples (3 +2 (in the 1st + 2nd Doxorubicin sampling periods)) will be collected in the younger children (\< 3 years) and a data set of max. 8 samples ( 5 + 3) will be collected in the older children. Samples will be taken at predefined time points/ time intervals.
* An additional DNA sample will be taken and analyzed for genetic polymorphisms. The influence of genotype on pharmacokinetics and metabolism will be investigated by appropriate statistical methods, including population pharmacokinetic analyses. Genes to study would include MDR1 and SLC22A16, both involved in the transport of doxorubicin and AKR1A1 and CBR1, both involved in the reduction of doxorubicin to doxorubicinol. Selected genotypes will be incorporated as covariates into the population pharmacokinetic models developed. The potential impact of genetic variation will be evaluated in the context of other sources of variability such as age, weight, gender etc

Pharmacokinetic Study of Doxorubicin in Children With Cancer

Phase II Pharmacokinetic Study to Assess the Age-dependency in the Clearance of Doxorubicin in Paediatric Patients With Solid Tumours and Leukaemia

Measure doxorubicin and doxorubicinol concentration in blood plasma. Collect samples at two different doxorubicin infusions.

Obtain one whole blood sample per patient, if separate consent was given.

Measure troponin T, troponin I, BNP, NT-proBNP, NT-proANP. Collect samples at two different doxorubicin infusions before and up to 1month after doxorubicin administration.

University Hospital Muenster

Skin and Connective Tissue Diseases

Sarcoma, Ewing

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Ewing Sarcoma

Melphalan

Thiotepa

All the patient who are affected by refractory or resistant or relapsed Soft tissue sarcoma o Ewing sarcoma who find an HLA compatible allogeneic donor and are submitted to Stem cell transplantation

administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell

Allogeneic hemopoietic stem cell transplant

Arcangelo Prete, MD, PhD, PI

This is a perspective multicentric study for the treatment of patients aged equal or less than 60 years and submitted to an allogeneic hematopoietic stem cell transplantation from an HLA compatible related or unrelated donor because affected by resistent or refractory or relapsed after autologous stem cell transplantation Ewing Sarcoma or Soft tissues sarcoma who did not benefit from conventional therapy.

Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas

Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas

S. Anna Hospital

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Dr Augusto Cavina

Liposarcoma

Sarcoma, Synovial

Neoplasms, Adipose Tissue

Synovial Sarcoma

TP-1287

TP-1287 is an oral phosphate prodrug of the CDK9 inhibitor, alvocidib. This is a Phase 1, open-label, dose-escalation, dose-expansion, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-1287 in patients with advanced metastatic or progressive solid tumors who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.

Primary Objective:

* During Dose Escalation: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-1287 in patients with advanced metastatic or progressive solid tumors who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.
* During Dose Escalation: To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-1287
* During Dose Expansion: To evaluate the preliminary antitumor activity of TP-1287 in terms of objective response rate (ORR) when administered at the RP2D in patients with sarcoma subtypes (ie, EWS, DDLPS and SS)
* During Dose Expansion: To evaluate the preliminary antitumor activity of TP-1287 in terms of clinical benefit rate (CBR) at week 16 when administered at the RP2D in patients with the defined sarcoma subtypes

Secondary Objectives:

* During Dose Escalation: To establish the pharmacokinetics of orally administered TP-1287
* During Dose Escalation: To observe patients for any evidence of antitumor activity of TP-1287 by objective radiographic assessment
* During Dose Escalation: To study the pharmacodynamics of TP-1287 therapy
* During Dose Expansion: To determine the median progression-free survival (PFS) rate in patients with sarcoma
* During Dose Expansion: To evaluate the safety of TP-1287 when administered at the RP2D in patients with sarcoma

Phase 1, First-in-human Study of Oral TP-1287 in Patients With Advanced Solid Tumors

A Phase 1, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-1287 to Patients With Advanced Solid Tumors

A DLT is defined as a drug-related toxicity that is observed to occur within the first 28 days of treatment

MTD will be determined based upon toxicity grades which are defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Objective radiographic assessment to be performed to determine antitumor activity by modified RECIST criteria

Clinical benefit rate assessment is to be performed for all patients with measureable disease at baseline by modified RECIST criteria, who achieve a CR, PR or SD and sustain the response for more than 16 weeks

To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-1287, MTD data to be reviewed

Sumitomo Pharma America, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacokinetic Study of Doxorubicin in Children With Cancer	NCT01095926	Wilms Tumor Neuroblastoma Soft Tissue Sar... Acute Lymphobla...	doxorubicin	- 17 Years	University Hospital Muenster
Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas	NCT00998361	Ewing Soft Tissue Sar...	Allogeneic hemo...	1 Month - 60 Years	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase 1, First-in-human Study of Oral TP-1287 in Patients With Advanced Solid Tumors	NCT03604783	Advanced Solid ... Sarcoma Ewing Sarcoma Dedifferentiate... Synovial Sarcom...	TP-1287	12 Years -	Sumitomo Pharma America, Inc.
Phase 1, First-in-human Study of Oral TP-1287 in Patients With Advanced Solid Tumors	NCT03604783	Advanced Solid ... Sarcoma Ewing Sarcoma Dedifferentiate... Synovial Sarcom...	TP-1287	12 Years -	Sumitomo Pharma America, Inc.

Spots Global Cancer Trial Database for ewing

Every month we try and update this database with for ewing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ewing

Every month we try and update this database with for ewing cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ewing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.