A Study of Safety, Tolerability, and Pk of rhMBL in Pediatric Hematology/Oncology Pts With Fever and Neutropenia

NCT00520325 | Withdrawn Phase 1

• 2 other identifiers: EZN-2232-03NCI # 07-C-0027
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer; Hematologic Diseases; Fever; Neutropenia

Keywords

MBL deficient oncologic hematologic pediatric fever neutropenia

Outcome Measures

Primary Outcomes (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.

  1 month

Secondary Outcomes (1)

• Determine the PK profile of intravenous rhMBL as a single dose escalation cohort design in MBL deficient pediatric oncology patients during episodes of fever and neutropenia.

  1 month

Study Arms (2)

0.5 mg/kg

OTHER

Drug: Intravenous recombinant human mannose binding lectin

1.0 mg/kg

OTHER

Drug: Intravenous recombinant human mannose binding lectin

Interventions

Intravenous recombinant human mannose binding lectin DRUG

Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg

0.5 mg/kg

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 at least 30 days after receiving their last treatment unless the patient is surgically or medically sterile.
• Patients with moderate or severe liver disease, as defined by:
• AST or ALT \>5 times upper limit of normal (ULN) OR Total bilirubin \>2.5 times ULN.
• Patients with poor venous access that would preclude intravenous drug delivery or multiple blood draws.
• Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an FDA approved drug) in the 30 days before scheduled administration of rhMBL.
• Known allergic reactions to MBL or other human plasma products.
• Patients on hemodialysis unable to tolerate the volume of IV fluid on non-dialysis days.

Sponsors & Collaborators

• Enzon Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Neoplasms; Hematologic Diseases; Fever; Neutropenia

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Study Officials

• Thomas Walsh, MD

  NIH/National Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 24, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 5, 2012

Record last verified: 2009-02