- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01987596
Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer
Prospective and Randomized Study of Fixed Versus Flexible Prophylactic Administration of Granulocyte Colony-Stimulating Factor (G-CSF) in Children With Cancer
Study Overview
Status
Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Osteosarcoma
- Neuroblastoma
- Retinoblastoma
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Wilms Tumor and Other Childhood Kidney Tumors
- Childhood Choroid Plexus Tumor
- Childhood Soft Tissue Sarcoma
- Childhood Medulloblastoma
- Childhood Pineoblastoma
- Childhood Supratentorial Primitive Neuroectodermal Tumor
Intervention / Treatment
Detailed Description
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.
ICT: Patients receive topotecan hydrochloride IV over 30 minutes on days 1-3, and ifosfamide and carboplatin as in ICE.
OPEC: Patients receive vincristine sulfate on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1-2; and cisplatin IV over 6 hours on day 4.
For all chemotherapy regimens, treatment repeats every 21 days for 2 courses. Patients are then randomized to 1 of 2 treatment arms.
ARM I (fixed filgrastim): Patients receive filgrastim subcutaneously (SC) once daily (QD) started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.
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.
After completion of the first filgrastim treatment, patients cross-over to the other filgrastim arm and repeat the same course of chemotherapy as before. After completion of the second filgrastim treatment, chemotherapy treatment may continue for up to 5 (OPEC) or 6 (ICE, ICT) courses in the absence of disease progression or unacceptable toxicity.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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:
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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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Time in days until absolute neutrophil count (ANC) recovery to greater than or equal to 1,000/uL from the start of chemotherapy
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From the start of the course until the first date the ANC reaches >= 1,000/uL post nadir, assessed up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Febrile Neutropenia
Time Frame: Up to 1 year
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occurrence of febrile neutropenia
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Up to 1 year
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Cumulative GCSF Dose
Time Frame: up until engraftment
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Cumulative GCSF dose - number of GCSF injections until ANC recovery greater than or equal to 1,000/uL from the start of chemotherapy
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up until engraftment
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Days to First G-CSF Dose
Time Frame: time to ANC 1000
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Time (in days) to first G-CSF dose
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time to ANC 1000
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Collaborators and Investigators
Investigators
- Principal Investigator: Maxim Yankelevich, Barbara Ann Karmanos Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Retinal Diseases
- Genetic Diseases, Inborn
- Glioma
- Neoplasms, Neuroepithelial
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Eye Diseases, Hereditary
- Neoplastic Syndromes, Hereditary
- Neoplasms, Complex and Mixed
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Neuroectodermal Tumors, Primitive, Peripheral
- Eye Neoplasms
- Retinal Neoplasms
- Cerebral Ventricle Neoplasms
- Sarcoma
- Medulloblastoma
- Osteosarcoma
- Neuroblastoma
- Retinoblastoma
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
- Wilms Tumor
- Pinealoma
- Choroid Plexus Neoplasms
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Lenograstim
Other Study ID Numbers
- 2013-062 (Other Identifier: Barbara Ann Karmanos Cancer Institute)
- P30CA022453 (U.S. NIH Grant/Contract)
- NCI-2013-02001 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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