A Study of Safety, Tolerability, and Pk of rhMBL in Pediatric Hematology/Oncology Pts With Fever … (NCT00520325) | Clinical Trial Compass
WithdrawnPhase 1
A Study of Safety, Tolerability, and Pk of rhMBL in Pediatric Hematology/Oncology Pts With Fever and Neutropenia
Stopped: Sponsor decision to terminate the study
0Started 2007-06
Plain-language summary
The goal of this clinical research study is to find the dose of EZN-2232 that can be given to MBL deficient pediatric cancer patients undergoing chemotherapy. The pharmacokinetics, pharmacodynamics, and safety of the study drug will also be studied.
Who can participate
Age range2 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment into the study:
* Children ages 2 to 17 receiving chemotherapy for hematological/oncological diseases.
* Patients must have documented MBL levels \<300 ng/mL in serum as evaluated in the screening protocol.
* Fever defined as an oral temperature equivalent of \>100.4°F (38°C).
* Neutropenia defined as an absolute neutrophil count ≤1,000/mm3 with the anticipation that the counts will fall below 500/mm3.
* Receiving broad spectrum antibiotics for fever and neutropenia.
* Patients with age-adjusted normal serum creatinine OR a creatinine clearance \>60 mL/min/1.73m2.
* Informed consent of the patient, parent or legally authorized representative obtained prior to entry.
* Reliable and willing to make themselves available for the duration of the study and to abide by the study restrictions.
Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for enrollment.
* Patients receiving the preparative regimen for a bone marrow or hematopoietic stem cell transplantation.
* Concurrent serious illness in the opinion of the principal investigator that could potentially interfere with protocol compliance.
* Patient is pregnant, breast feeding or planning a pregnancy during the course of the study.
* Sexually active male and female patients not using an acceptable barrier method of contraception or practicing abstinence throughout the study and for …
What they're measuring
1
Determine the safety and tolerability of intravenous rhMBL administered at dosages of 0.5 and 1.0 mg/kg to MBL deficient pediatric hematology/oncology patients during episodes of fever and neutropenia.