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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Prospective and Randomized Study of Fixed Versus Flexible Prophylactic Administration of Granulocyte Colony-Stimulating Factor (G-CSF) in Children With Cancer

Brief Summary: 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To compare the effect of flexible vs. fixed administration of G-CSF (filgrastim) on the parameters of hematological recovery including duration of absolute neutrophil count (ANC) < 500/uL; time to ANC recovery >= 1,000/uL and time to platelet recovery >= 75,000/uL in children receiving myelotoxic chemotherapy.

SECONDARY OBJECTIVES:

I. To compare the effect of flexible vs. fixed administration of G-CSF on the incidence of febrile neutropenia and number of hospital days on antibiotics following myelotoxic chemotherapy.

II. To evaluate the number of days of platelet transfusion events after chemotherapy cycles with flexible vs. fixed administration of G-CSF.

III. To evaluate on the incidence and duration of G-CSF-related side effects including extremities/back pain and headaches after chemotherapy courses followed by flexible vs. fixed administration of G-CSF.

IV. To evaluate the peripheral blood progenitor responses and subsets of progenitor cells (cluster of differentiation [CD]34/41/61/117/10/19/11b/33) to chemotherapy followed by flexible vs. fixed administration of G-CSF.

OUTLINE:

CHEMOTHERAPY: Depending on their diagnosis patients are assigned to 1 of 3 chemotherapy regimens.

ICE: Patients receive etoposide intravenously (IV) over 1 hour on days 1-3, ifosfamide IV over 3 hours on days 1-3, and carboplatin IV over 1 hour on day 4. Patients with recurrent Hodgkin lymphoma receive etoposide and ifosfamide on days 1-3 and carboplatin on day 3.

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Sponsor: Barbara Ann Karmanos Cancer Institute

Current Primary Outcome: 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 ]

Original Primary Outcome:

• Duration (days) of ANC less than 500/uL [ Time Frame: Up to 1 year ]
  General linear model (GLM) procedure will be performed to examine differences between groups.
• 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 ]
  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.
• Days to transfusion unsupported platelet count greater than or equal to 75,000/uL from the start of chemotherapy [ Time Frame: From the start of the course until the first date the platelet count reaches >= 75,000/uL without platelet transfusion support, assessed up to 1 year ]
  Kaplan-Meier approach will be used.

Current Secondary Outcome:

• Incidence of febrile neutropenia [ Time Frame: Up to 1 year ]
  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 ]
  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 ]
  GLM procedure will be performed to examine differences between groups.
• Days of filgrastim administration [ Time Frame: Up to 1 year ]
  GLM procedure will be performed to examine differences between groups.
• Incidence of filgrastim related pain [ Time Frame: Up to 1 year ]
  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 ]
  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 ]
  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 ]
  GLM procedure will be performed to examine differences between groups.

Original Secondary Outcome: Same as current

Information By: Barbara Ann Karmanos Cancer Institute

Dates:
Date Received: November 12, 2013
Date Started: August 2013
Date Completion: September 30, 2017
Last Updated: March 28, 2017
Last Verified: March 2017