Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001911
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Interleukin-12 in the Treatment of Severe Nontuberculous Mycobacterial Infections
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Interleukin-12 in the Treatment of Severe Nontuberculous Mycobacterial Infections
Status:
COMPLETED
Status Verified Date:
2003-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the safety and effectiveness of a drug called interleukin-12 IL-12 in fighting severe infectious other than tuberculosis caused by a group of bacteria called mycobacteria IL-12 is similar to a substance the body produces naturally to strengthen immune function infection-fighting ability It works by stimulating white blood cells to increase production of a chemical called interferon gamma which can improve or cure mycobacterial infections in some patients
In previous studies IL-12 has improved immune function against mycobacteria in test tube experiments and in mice A recent study of three patients with mycobacterial infections treated with the drug showed encouraging results The drug has also been studied more extensively in patients with cancer HIV infection and hepatitis C
Patients in this study will receive IL-12 injections under the skin twice a week for one year They will be taught how to self-administer the drug but a home care nurse or a physician may also give the injections The drug dosage will be increased each week to determine the safest and most effective dose for fighting this infection If intolerable side effects develop at a certain dose the previous dose level will be used for the next injection That dose will then be used for the rest of the study unless unacceptable side effects develop at that level in which case the dose will again be lowered Patients will receive an antibiotic against mycobacteria
Physical examinations and blood and urine tests will be done once a month for at least the first year and then every 3 months the following year to evaluate kidney liver and immune function The first evaluation-at the start of the study-is done on an inpatient basis
In previous studies IL-12 has improved immune function against mycobacteria in test tube experiments and in mice A recent study of three patients with mycobacterial infections treated with the drug showed encouraging results The drug has also been studied more extensively in patients with cancer HIV infection and hepatitis C
Patients in this study will receive IL-12 injections under the skin twice a week for one year They will be taught how to self-administer the drug but a home care nurse or a physician may also give the injections The drug dosage will be increased each week to determine the safest and most effective dose for fighting this infection If intolerable side effects develop at a certain dose the previous dose level will be used for the next injection That dose will then be used for the rest of the study unless unacceptable side effects develop at that level in which case the dose will again be lowered Patients will receive an antibiotic against mycobacteria
Physical examinations and blood and urine tests will be done once a month for at least the first year and then every 3 months the following year to evaluate kidney liver and immune function The first evaluation-at the start of the study-is done on an inpatient basis
Detailed Description:
Severe nontuberculous mycobacterial infections in patients who are not infected with HIV have been shown to be due to abnormalities in the pathways that generate or use interferon gamma IFN gamma In some of these patients treatment with IFN gamma has been effective in improving or curing these infections Recently interleukin-12 IL-12 has been shown to be a potent inducer of IFN gamma along with other cytokines Experiments in animals and preliminary experience by us in humans suggests that IL-12 may be an important adjunct to antimycobacterial therapy We seek to use IL-12 in a phase III trial in the treatment of severe nontuberculous mycobacterial infections in patients who have not been cured by the best tolerated conventional therapy with IFN gamma Patients will be studied for inborn or acquired immune defects as well as IL-12 responsiveness in vitro under protocol 93-I-0119 Detection and Characterization of Host Defense Defects Patients will receive IL-12 subcutaneously 2 times weekly We will use an intrapatient dose escalation protocol ranging from 20 ngkg to 300 ngkg depending on the highest dose tolerated by the patient We expect this study to yield valuable information about tolerance and toxicity We seek to treat 10 patients over the next 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-I-0147 | None | None | None |