Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Neoplasm Metastasis

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)

Escalate the MLD in patients with ≥ 2 lung metastases

Stereotactic Body Radiotherapy (SBRT)

3-5 fractions per tumor within one treatment session or sequential within one month

Heike Peulen, MD

Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.

A phase I/II multicenter trial will be conducted in patients with medically inoperable with peripheral non small cell lung cancer (NSCLC) \> 5 cm without lymph node involvement (group A) or medically with ≥ 2 or more lung metastases (group B). Radiation pneumonitis is expected to be dose-limiting in these patients and there is evidence that the incidence is predicted by the mean lung dose (MLD). The MLD escalation will be performed separately in both patient groups, using a time-to-event continual reassessment method (TITE-CRM). All patients will receive 3-5 fractions SBRT to the lung tumor(s), with a minimum mean PTV dose ≥ 42 Gy. Fraction size may be downscaled based on the MLD constraint.

Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously

VOLUMES Treatment of Larger Tumor Volumes or ≥ 2 Lung Tumors Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study

The assessment of the maximum mean lung dose that can be safely treated with SBRT and that is associated with a 20% probability of the DLT.

Determine the local control and regional control as a function of the mean lung dose, the largest toxicity effects as a function of the MLD and the overall survival.

valuate the increase or decrease of physical discomfort.

The Netherlands Cancer Institute

Blood and Lymph Conditions

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Syndrome

Hematologic Neoplasms

Immunologic Deficiency Syndromes

Anemia

Anemia, Aplastic

Metabolism, Inborn Errors

Mucopolysaccharidosis II

Primary Immunodeficiency Diseases

Hematologic Diseases

Genetic Diseases, Inborn

Metabolic Diseases

Bone Marrow Failure Disorders

Pancytopenia

Bone Marrow Diseases

Aplastic Anemia

Hurler Syndrome

Mucopolysaccharidosis Type II

20% of UCB is ALDHbr sorted and primed and give on transplant day after conventional graft

20% of UCB is ALDHbr freshly sorted and give on transplant day 4-8 hrs after conventional graft

patient receives 1 conventional UCB unit and 1 unit that has been ALDHbr sorted and primed

Patient receives 1 UCB unit and a second UCB unit that has been freshly ALDHbr sorted

ALDHbr Umbilical Cord Blood Cells

Joanne Kurtzberg, MD

The main purpose of this investigational (not approved by the FDA) Phase I research is to test whether transplantation of umbilical cord blood cells can be safely supplemented with a transfusion of a portion of these cells that have been sorted (collected from a special machine called a cell sorter) and then either infused a few hours after the standard transplant or for some patients grown in a special system in the laboratory prior to the transplant, designed to increase the number of stem cells transplanted. This system is currently in the early phases of testing.

The main purpose of this study is to test whether transplantation of umbilical cord blood cells can be safely supplemented with transfusion of a portion of these cells that have been grown in a special system (designed to increase the number of cells transplanted) in the laboratory prior to the transplant. This system is currently in the early phases of testing in a FDA-IND-sponsored clinical trial. If the patient consents to participate in this study, approximately 1/5th (20%) of the cord blood unit selected for the transplant will be treated per protocol. The first 3 patients will receive ALDHbr sorted cells but not primed in culture. This is to test the safety of the ALDHbr cells. The treated cells will be given to the patient on the day of transplant approximately 4 hours after the standard or conventional transplant which will be given from the 80% fraction of the cord blood unit. A total of 26 evaluable patients are to be enrolled as outlined below (protocol has been amended to allow this enrollment):

* 10 evaluable patients who received ALDHbr freshly sorted cells (20% portion)
* 10 evaluable patients who received ALDHbr sorted and cytokine primed cells (20% portion)
* 3 evaluable patients who received a conventional cord blood unit and a cord blood unit that has been ALDHbr sorted (sort of the UCB unit will be done on Day -1 due to the time it takes to actually perform the sort)
* 3 evaluable patients who received a conventional cord blood unit and a cord blood unit that has been ALDHbr sorted and cytokine primed (sort and priming will be done on day -5 as described later in the protocol)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously	NCT01543672	Lung Cancer Metastatic Lung...	Stereotactic Bo... Stereotactic Bo...	18 Years -	The Netherlands Cancer Institute
Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously	NCT01543672	Lung Cancer Metastatic Lung...	Stereotactic Bo... Stereotactic Bo...	18 Years -	The Netherlands Cancer Institute
Unrelated Umbilical Cord Blood Transplantation Augmented With ALDHbr Umbilical Cord Blood Cells	NCT00692926	MDS Anemia, Aplasti... Inborn Errors o... Congenital Marr... Congenital Immu...	ALDHbr Umbilica...	- 55 Years	Duke University
Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously	NCT01543672	Lung Cancer Metastatic Lung...	Stereotactic Bo... Stereotactic Bo...	18 Years -	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for mld

Every month we try and update this database with for mld 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 mld

Every month we try and update this database with for mld 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 mld 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.