Neutrophil Extracellular Traps (NETs) Formation Following Chemotherapy and Their Role in Antitumor Activity

Pediatric Hematological Malignancies Clinical Trial

Official title:

Neutrophil Extracellular Traps (NETs) Formation Following Chemotherapy for Pediatric Hematological and Solid Tumors, and Its Relation to Other Neutrophil Functions and the Role of NETs in Antitumor Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01533779
• Other study ID #: 0592-11-TLV
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2012
• Last updated: February 14, 2012
• Start date: February 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Sivan Achituv, MD
• Phone: 972-527360718
• Email: sivanbrg[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Examine neutrophil extracellular traps (NETs) formation, in relation to other neutrophil functions like chemotaxis, superoxide production, hydrogen peroxide production, and the presence of myeloperoxidase, in pediatric patients undergoing chemotherpy for solid and hematological malignancies. This data could shed new light on the mechanism responsible for the increased susceptibility to infection among these patients and aid in improving their prophylactic antimicrobial treatment.

NETs formation against tumor cell lines and their ability to kill tumor cells will also be examined. The finding of NETs activity against tumor cells could have a major contribution to the investigators understanding of the function of the immune system against cancer.

Description:

Neutrophil function, including NETs formation, chemotaxis, superoxide production, hydrogen peroxide production, and the presence of myeloperoxidase, will be examined in 50 pediatric patientsundergoing chemotherapy for solid and hematological malignancies. Children with the following malignancies will be examined: acute lymphoblastic leukemia,acute myelogenous leukemia,Hodgkin's lymphoma,non-Hodgkin's lymphoma, primary bone sarcoma,rhabdomyosarcoma,non-rhabdomyosarcoma,neuroblastoma,Wilms' tumor,hepatoblastoma or hepatocellular carcinoma,germ cell tumors, and hystiocytosis. Also those with brain tumors such as medulloblastom,low grade glioma,high grade glioma,ependymoma,and embryonal and pineal region tumors. Data gathered on the patients will include background data (age, gender, ethnicity) and background diseases, data on current illness (histologic type, grade, stage, response treatment,infectious episodes), and on the use of ranulocyte-colony stimulating factor (G-CSF).

The following time points will be examined:

1. At diagnosis, before initiation of chemotherapy.

2. immediately before the 2nd course.

3. After the middle course.

4. A month after the last course.

5. Three months after the last course.

6. In acute myelogenous leukemia and acute lymphoblastic leukemia,time points also include the middle of the maintenance course and 3 months after the end of maintenance.

An additional blood examination will be used to examine NETs formation against tumor cell lines and their ability to kill tumor cells.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

Included in the study were patients with:

• Acute lymphoblastic leukemia or acute myelogenous leukemia.

• Hodgkin's lymphoma or non-Hodgkin's lymphoma.

• Primary bone sarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma, neuroblastoma, Wilms' tumor, hepatoblastoma or hepatocellular carcinoma, hystiocytosis, and germ cell tumors.

• Medulloblastoma, low grade glioma, high grade glioma, ependymoma, and embryonal and pineal region tumors.

Exclusion Criteria:

• A severe background disease that may affect Neutrophil function (e.g., diabetes, lupus).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasms
• Pediatric Hematological Malignancies
• Pediatric Solid Malignancies

Locations

Country	Name	City	State
Israel	Department of pediatric hemato-oncology, Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (3)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Max Planck Institute for Infection Biology, Meir Medical Center

Country where clinical trial is conducted

Israel,