| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001756 |
Purpose
This study will investigate mast cell precursors that circulate in the blood. In a group of diseases collectively known as mastocytosis, mast cells accumulate in abnormal amounts in the skin, lymphoid tissues, bone marrow, liver and spleen. Some forms of mastocytosis have a generally good prognosis; for others, the prognosis is poorer. There is no known cure for any form of the disease. A better understanding of mast cells and how they respond to certain substances may provide insights that will lead to effective treatments for mastocytosis.
Patients with systemic mastocytosis and normal healthy volunteers between the ages of 20 and 60 may be eligible for this 8-day study. Participants will undergo the following procedures:
| Condition |
|
Mastocytosis |
| Drug Information available for: | Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor |
| Study Type: | Observational |
| Official Title: | The Characterization of CD34+ Derived Mast Cell Precursors Mobilized by Administration of Granulocyte Colony Stimulating Factor |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 1997 |
The purpose of this protocol is to obtain large numbers of CD34+ cells from the peripheral blood of patients with systemic mastocytosis and normal volunteers by leukapheresis for culture and characterization of mast cell progenitor cells and their response to various cytokines and anti-mitotic agents. Granulocyte colony stimulating factor (G-CSF) will be administered to normal volunteers at doses of 10 microg/kg/day as a single subcutaneous dose daily for 5 days. Normal volunteers and mastocytosis patients will be adults of both sexes from 18 to 60 years of age. Normal volunteers and patients will undergo a single leukapheresis at day 7. A small number of normal volunteers and all mastocytosis patients will undergo leukapheresis without G-CSF mobilization. This is not a therapeutic protocol and does not involve reinfusion of any manipulated cells, viruses or DNA constructs back into human subjects.
Eligibility
| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Normal Volunteers - ages 18-60:
Healthy without active infection or history of recurrent infections.
Normal renal function (creatinine less than or equal to 1.5 mg/dl; less than or equal to 1+ proteinuria); normal hepatic function (bilirubin less than or equal to 1.5 mg/dl); normal hematologic function (WBC greater than or equal to 3000/mm(3); granulocytes greater than or equal to 1500/mm(3); platelets greater than or equal to 175,000; hemoglobin greater than or equal to 12.5).
Normal female volunteers of childbearing potential may be entered if using contraception, and with a negative urine pregnancy test determined the day before beginning G-CSF administration.
Patients - ages 18-60:
Systemic mastocytosis patients must have mast cell hyperplasia compatible with a diagnosis of systemic mastocytosis; and be without active infection or history of recurrent infections.
Preserved renal function (creatinine less than or equal to 2mg/dl; less than or equal to 2+ proteinuria); preserved hepatic function (bilirubin less than or equal to 1.5 mg/dl); preserved hematologic function (WBC greater than or equal to 3000/mm(3), granulocytes greater than or equal to 1500/mm(3); platelets greater than or equal to 175,000; hemoglobin greater than or equal to 12.5).
Normal female volunteers of childbearing potential may be entered if using effective contraception, and with a negative urine pregnancy test determined the day before beginning G-CSF administration.
EXCLUSION CRITERIA:
NORMAL VOLUNTEERS:
Active bacterial, fungal or viral infections.
HIV+, HCV+.
Pregnancy or lactation.
History of autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum or similar disorder.
Use of any investigative drugs.
History of splenic trauma.
Any condition which in the judgment of the PI might significantly increase the risks of mobilization or aphereses.
SYSTEMIC MASTOCYTOSIS PATIENTS:
Active bacterial, fungal or viral infections.
HIV+, HCV+.
Patients taking any other growth factors, cytokines or investigative drugs.
Patients hemodynamically unstable (blood pressure systolic of lower than 105 or diastolic lower than 65).
Pregnancy or lactation.
History of autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum or similar disorder.
Any condition which in the judgment of the PI might significantly increase the risks of mobilization or aphereses.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |||||
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting | ||||
| Bethesda, Maryland, United States, 20892 | |||||
More Information
NIH Clinical Center Detailed Web Page
|
| Study ID Numbers: | 980027, 98-I-0027 |
| First Received: | November 3, 1999 |
| Last Updated: | August 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001756 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|
|
