|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Enzon Pharmaceuticals, Inc. |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00886496 |
Purpose
RATIONALE: Recombinant human mannose-binding lectin (MBL) may be effective in preventing infection in young patients with fever and neutropenia receiving chemotherapy for blood disease or cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of recombinant human mannose-binding lectin in treating young patients with MBL deficiency and fever and neutropenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Fever, Sweats, and Hot Flashes Infection Leukemia Lymphoma Myelodysplastic Syndromes Neutropenia Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: recombinant human mannose-binding lectin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Multi-Center Study of the Safety, Tolerability, Pharmacokinetics and Dose Escalation of Intravenous Recombinant Human Mannose-Binding-Lectin (rhMBL) in MBL Deficient Pediatric Hematology/Oncology Patients With Fever and Neutropenia |
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, multicenter, open-label, prospective, cohort study. Patients are assigned to 1 of 2 treatment groups.
Patients undergo blood collection periodically during study for pharmacokinetic, pharmacodynamic, MBL immunogenicity, and opsonization/phagocytosis studies.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet all of the following criteria:
PATIENT CHARACTERISTICS:
Creatinine clearance > 60 mL/min OR creatinine based on age as follows:
PRIOR CONCURRENT THERAPY:
More than 30 days since prior investigational agents
Contacts and Locations| United States, California | |
| Children's Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Antonio Arrieta, MD 714-532-8403 | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010-2970 | |
| Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Theoklis Zaoutis, MD 215-590-1000 zaoutis@email.chop.edu | |
| Principal Investigator: | Thomas J. Walsh, MD | NCI - Pediatric Oncology Branch |
More Information
| ClinicalTrials.gov Identifier: | NCT00886496 History of Changes |
| Other Study ID Numbers: | CDR0000523819, ENZON-ENZ-2232-03, NCI-07-C-0027 |
| Study First Received: | April 21, 2009 |
| Last Updated: | March 13, 2012 |
| Health Authority: | Unspecified |
|
unspecified childhood solid tumor, protocol specific fever, sweats, and hot flashes neutropenia infection recurrent childhood small noncleaved cell lymphoma stage I and II childhood small noncleaved cell lymphoma stage I childhood small noncleaved cell lymphoma stage II childhood small noncleaved cell lymphoma stage III and IV childhood small noncleaved cell lymphoma stage III childhood small noncleaved cell lymphoma stage IV childhood small noncleaved cell lymphoma recurrent childhood lymphoblastic lymphoma stage I and II childhood lymphoblastic lymphoma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma |
stage III and IV childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma childhood Burkitt lymphoma recurrent/refractory childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage II childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma childhood acute lymphoblastic leukemia in remission recurrent childhood acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
|
Fever Leukemia Lymphoma Myelodysplastic Syndromes Preleukemia Neutropenia Lymphoma, Non-Hodgkin Hot Flashes Body Temperature Changes Signs and Symptoms Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Agranulocytosis Leukopenia Leukocyte Disorders |