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A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia Clinical research trials and A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia. A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia clinical trial. Participants frequently get the best healthcare available for their A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia  A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia
A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia
For Condition: Neutropenia,Mycoses
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Fever and infection are serious complications of chemotherapy treatment, especially when white blood counts are low. When the number of white blood cells is below 500/mm3, a condition called neutropenia is present. A neutropenic person has a high risk of getting an infection. Because a serious infection may be difficult to detect when a person is neutropenic, antibiotic treatment is needed at the first sign of fever. However, antibiotics do not kill fungus infections, so doctors usually wait for signs of fungal infection before treating it. MK-0991 has been shown to be effective in preventing life-threatening fungal infections in animals with neutropenia and in treating such infections in adult humans. This is the first study of MK-0991 in patients under age 18. This study will help determine the correct dose and assess the safety of the drug for children. About 32 children will participate in the study. MK-0991 will be administered daily through a catheter for a duration of about an hour. The medication will be continued until recovery from neutropenia, possibly up to 4 weeks. A follow-up evaluation will be done 14 days after the last dose. Small amounts of blood will be drawn periodically during the study to measure drug levels and check for side effects. If fever continues for more than 5 days despite treatment, MK-0991 will be stopped and the standard treatment of amphotericin B will be given instead. Common side effects of MK-0991 include fever, inflammation of a vein, and increased liver enzymes.
Details: The objective of this study is to evaluate the safety, tolerance, and pharmacokinetics of caspofungin acetate, a novel echinocandin (cell wall-active antifungal lipopeptide), as early empirical therapy for prevention of fungal infections in immunocompromised children. The study is designed as a multicenter open label, sequential dose escalation study of intravenous caspofungin acetate. Intravenous caspofungin acetate will be administered daily as a one hour infusion to patients with new onset of fever and neutropenia (absolute neutrophil count less than or equal to 500 mm (3)) who will be initiated onto broad spectrum empirical antibacterial therapy. The patient population consists of children ages 2 to 17 years of age; two age cohorts will be studied (2-11, 12-17). Dosage levels will be 50mg/m(2) day (not to exceed 70 mg) and 70 mg/m(2) (not to exceed 70 mg). The planned sample size is 32 patients (a maximum of 64 patients may participate in the study allowing for one replacement patient for each patient enrolled). At each dosage level, a total of 8 patients will be enrolled into each age cohort (2-11, 12-17); a total of 16 patients will be enrolled at each dosage level. The first group of patients will receive caspofungin acetate at 50mg/m(2) (not to exceed 70 mg). Study drug will continue until recovery from neutropenia (ANC post nadir greater than or equal to 250/ mm (3)) or until the initiation of conventional deoxycholate amphotericin B or a lipid formulation of amphotericin B for either empirical antifungal therapy or for proven fungal infection. Patients may receive caspofungin acetate for a maximum duration of 28 days. For any patient who meets criteria to start standard empirical antifungal therapy with conventional deoxycholate amphotericin B or a lipid formulation of amphotericin B (fever greater than 38.0 C despite greater than or equal to 96 hours of neutropenia and broad spectrum antibacterial therapy) or who has a proven breakthrough fungal infection, caspofungin acetate will be discontinued and conventional deoxycholate amphotericin B or a lipid formulation of amphotericin B will be initiated.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Children ages 2-17 with one or more of the following conditions: leukemia, lymphoma or other cancers; bone marrow or peripheral stem cell transplantation; aplastic anemia. Chemotherapy anticipated to incur greater than 10 days of neutropenia. Patient has an absolute neutrophil count less than or equal to 500/mm (3) AND at least one recorded fever greater than 38 degrees Celsius within 24 hours of screening. Patient has or will receive parenteral systemic antibacterial therapy for fever and neutropenia within 48 hours of screening. For female adolescents of childbearing potential, patient has a negative serum or urine pregnancy test prior to enrollment into the study and will subsequently use adequate birth control measures as defined by the investigator (Note: oral contraceptives should not be used as the sole method of birth control because the effect of caspofungin acetate on the efficacy of oral contraceptives has not yet been established). Patient has a functioning central venous catheter in place at screening. Patient or guardian understands the procedures and agrees to the patient's participation by providing written informed consent. Assent will also be obtained from minors capable of understanding. EXCLUSION CRITERIA: Patient has proven invasive fungal infection at the time of enrollment. Patient has abnormal laboratory values: INR/ 1.6 (INR greater than 4.0, if patients are receiving anticoagulants); AST or ALT greater than 3 times the upper limit of normal for age; Alkaline phosphatase greater than 5 times the upper limit of normal for age. (Note: Patients with an elevated alkaline phosphatase greater than 5 times the ULN which is thought to be related to bony metastases or other suspected bony processes may be enrolled on a case by case basis following discussion with the sponsor). Patient is hemodynamically unstable, exhibits hemodynamic compromise, or not expected to survive at least 5 days. Patient is pregnant or breast feeding. Patients has a diagnosis of acute hepatitis or cirrhosis due to any cause. Patient has or is participating in or be participating in any other clinical study involving the administration of an investigational antibiotic or antifungal drug within 14 days prior to study or during the course of study. Patients previously enrolled into this study. Patient has any condition or concomitant illness which, in the opinion of the investigator, might confuse the results of the study or pose additional risk in administering the study drugs to the patient. Patient is taking rifampin, cyclosporin A, phenytoin, carbamazepine, or phenobarbital or other antifungal treatments (except fluconazole). Patient has documented HIV infection of any stage. Patient has a history of allergy, hypersensitivity, or any serious reaction to echinocandin antifungals.
Total Enrollment: 64
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010084; 01-C-0084
Study Start Date: February 3, 2001
Record last reviewed: May 16, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011219
Other Neutropenia Studies:
1. Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
2. A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
3. Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients with Graft vs. Host Disease
4. Emergency Use of Voriconazole in Patients with Life-Threatening Invasive Fungal Infections
5. Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children with Fever and Neutropenia
Related Studies:
Other Neutropenia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia
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