Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Barbara Ann Karmanos Cancer Institute
Sponsor:
Collaborators:
Children's Hospital of Michigan
Information provided by (Responsible Party):
Maxim Yankelevich, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01987596
First received: November 12, 2013
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

This randomized phase III trial studies flexible administration of filgrastim after combination chemotherapy to see how well it works compared to fixed administration of filgrastim in decreasing side effects of chemotherapy in younger patients with cancer. Cancer chemotherapy frequently results in neutropenia (low blood counts) when patients are susceptible to severe infections. A medicine called G-CSF (filgrastim) stimulates bone marrow and daily filgrastim shots are commonly used to shorten neutropenic periods and decrease infections after chemotherapy. Since filgrastim is customarily used on a fixed schedule starting early after chemotherapy and there are data that early doses may not be needed, this study tests new flexible schedule of filgrastim to optimize its use by reducing the number of painful shots, cost of treatment, and filgrastim side effects in children with cancer receiving chemotherapy.


Condition Intervention Phase
Childhood Choroid Plexus Tumor
Childhood Medulloblastoma
Childhood Pineoblastoma
Childhood Soft Tissue Sarcoma
Childhood Supratentorial Primitive Neuroectodermal Tumor
Neuroblastoma
Osteosarcoma
Retinoblastoma
Wilms Tumor and Other Childhood Kidney Tumors
Recurrent/Refractory Childhood Hodgkin Lymphoma
Unspecified Childhood Solid Tumor, Protocol Specific
Biological: filgrastim
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prospective and Randomized Study of Fixed Versus Flexible Prophylactic Administration of Granulocyte Colony-Stimulating Factor (G-CSF) in Children With Cancer

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Days to ANC greater than or equal to 1,000/uL from the start of chemotherapy [ Time Frame: From the start of the course until the first date the ANC reaches >= 1,000/uL post nadir, assessed up to 1 year ] [ Designated as safety issue: No ]
    The analysis will be reported by displaying mean values (for each treatment in each sequence) as well as their differences, and 95% confidence intervals for the mean difference between treatments (adjusting for the period effect). Kaplan-Meier approach will be used.


Secondary Outcome Measures:
  • Incidence of febrile neutropenia [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Categorically scaled variables will be presented as numbers, ratios, and percentages. The McNemar's test will be used to assess the statistical significance of categorical data.

  • Incidence of hospitalization [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Categorically scaled variables will be presented as numbers, ratios, and percentages. The McNemar's test will be used to assess the statistical significance of categorical data.

  • Number of platelet transfusions per chemotherapy cycle [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    GLM procedure will be performed to examine differences between groups.

  • Days of filgrastim administration [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    GLM procedure will be performed to examine differences between groups.

  • Incidence of filgrastim related pain [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Categorically scaled variables will be presented as numbers, ratios, and percentages. The McNemar's test will be used to assess the statistical significance of categorical data.

  • Duration of filgrastim related pain [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Univariately, continuously scaled variables will be presented as means, standard deviations, medians, ranges, and interquartile ranges.

  • Incidence of bacteremia [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Categorically scaled variables will be presented as numbers, ratios, and percentages. The McNemar's test will be used to assess the statistical significance of categorical data.

  • Percentage of progenitor cells in peripheral blood [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    GLM procedure will be performed to examine differences between groups.


Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (fixed filgrastim)
Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.
Biological: filgrastim
Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
Other Names:
  • G-CSF
  • Neupogen
Experimental: Arm II (flexible filgrastim)
Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
Biological: filgrastim
Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
Other Names:
  • G-CSF
  • Neupogen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have or have had at initial diagnosis, histologic proof of their malignancy; young children with primary embryonal brain tumor treated according to Head Start protocol are eligible; subjects with bone marrow involvement are NOT eligible for study
  • Patients will receive repeated cycles of identical chemotherapy that will likely result in grades III-IV hematological toxicity; patients will be treated outside of Children's Oncology Group (COG) protocols with specific requirements for schedule of G-CSF administration; the following categories of patients treated at Children's Hospital of Michigan are eligible for this study:

    • Patients with brain tumors treated according to Head Start II protocol with vincristine, etoposide, cyclophosphamide, and cisplatin (OPEC) chemotherapy;
    • Patients with recurrent Hodgkin lymphoma treated with ICE (ifosfamide, carboplatin, etoposide) chemotherapy;
    • Patients with recurrent solid tumors including sarcomas, Wilms' tumor, neuroblastomas, or brain tumors treated with high dose ICE or ICT (ifosfamide, carboplatin, topotecan) chemotherapy
    • Patients with UH Wilms' tumor treated with CE (cyclophosphamide, etoposide); patients with neuroblastoma treated with CE (carboplatin, etoposide);
    • Patients with soft tissue sarcomas treated with IA (ifosfamide, doxorubicin);
    • Patients with osteosarcoma treated with high dose ifosfamide
  • Subjects must have fully recovered from the toxic effects of any prior therapy; at least 3 weeks should have elapsed since the last dose of chemotherapy (6 weeks in the case of nitrosourea containing therapy); subjects must have recovered from previous colony-stimulating factor therapy and have been off colony-stimulating factors (G-CSF, granulocyte macrophage colony-stimulating factor [GM-CSF], interleukin [IL]-11) for more than 10 days and off erythropoietin for 30 days
  • ANC > 1000/uL
  • Platelet count > 100,000/uL
  • Creatinine clearance or glomerular filtration rate (GFR) which is greater than or equal to 70 ml/min/1.73 m^2
  • Bilirubin less than 1.5 x normal limit (NL)
  • Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) less than 2.5 x NL for age
  • Subjects should have a normal ejection fraction (per institutional limits), no evidence of cardiac arrhythmias requiring therapy, and a fractional shortening of > 28%
  • All subjects must have a life expectancy of 12 weeks or more
  • Diagnostic categories

    • Sarcoma (soft tissue and bone)
    • Kidney tumors
    • Brain tumors
    • Other solid tumors (gonadal and germ cell tumors, retinoblastoma, neuroblastoma, and miscellaneous tumors)
    • Hodgkin lymphoma
  • Performance status must be > 60 from Lansky (age 1 to 16) or Karnofsky (age > 16)

Exclusion Criteria:

  • Subjects with any of the following will NOT be eligible for study:

    • Bone marrow involvement
    • Active myelogenous leukemia, or history of myelogenous leukemia
    • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987596

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Maxim Y. Yankelevich    313-745-5515    myankele@med.wayne.edu   
Principal Investigator: Maxim Y. Yankelevich         
Sub-Investigator: Jeffrey Taub         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Children's Hospital of Michigan
Investigators
Principal Investigator: Maxim Yankelevich Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Maxim Yankelevich, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01987596     History of Changes
Other Study ID Numbers: 2013-062, NCI-2013-02001, 2013-062, P30CA022453
Study First Received: November 12, 2013
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Choroid Plexus Neoplasms
Hodgkin Disease
Kidney Neoplasms
Medulloblastoma
Neuroblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Osteosarcoma
Retinoblastoma
Sarcoma
Wilms Tumor
Brain Diseases
Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Cerebral Ventricle Neoplasms
Eye Diseases
Eye Neoplasms
Genetic Diseases, Inborn
Glioma
Immune System Diseases
Immunoproliferative Disorders
Kidney Diseases
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Bone Tissue

ClinicalTrials.gov processed this record on May 29, 2015