Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
NCT ID: NCT00003597
Last Updated: 2014-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
1998-11-30
2005-09-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy.
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Detailed Description
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* Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin in children with solid tumors receiving myelosuppressive chemotherapy with ifosfamide, carboplatin, and etoposide (ICE).
* Determine a safe dose of recombinant human thrombopoietin with filgrastim (G-CSF) in this patient population.
* Evaluate the time to platelet count recovery following chemotherapy in this patient population.
* Evaluate the depth and duration of neutropenia and thrombocytopenia and the number of platelet transfusion events in this patient population.
OUTLINE: This is a dose escalation study of recombinant human thrombopoietin.
All patients receive chemotherapy consisting of carboplatin IV over 60 minutes on days 0 and 1 and etoposide and ifosfamide IV over 60 minutes on days 0-4. Chemotherapy is continued in the absence of disease progression or unacceptable toxicity for a maximum of 6 courses every 21 days.
Cohorts of 3-6 patients each receive escalating doses of recombinant human thrombopoietin IV on days 4, 6, 8, 10, and 12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 2 patients experience dose limiting toxicity. After the MTD is determined an additional cohort of patients are treated at this dose level every other day on days 4-20. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until absolute neutrophil count is greater than 1000/mm3 for 2 consecutive days or day 33.
PROJECTED ACCRUAL: A total of 24 evaluable patients will be accrued for this study.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Cohort 1
Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5. All patients receive recombinant human thrombopoietin (rhTPO). rhTPO began on the last day of ICE (Ifosfamide, Carboplatin and Etoposide) chemotherapy (Day 4) and subsequent doses will be administered on Days 6, 8, 10 and 12 (5 doses total). The initial dose of rhTPO was 1.2 μg/kg/dose and was subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated. Therapy will continue for maximum six courses. Pharmacokinetic data will be obtained (during course one only).
recombinant human thrombopoietin
carboplatin
etoposide
ifosfamide
G-CSF
Cohort 2
Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5. All patients receive recombinant human thrombopoietin (rhTPO). The dose of rhTPO 1.2 μg/kg/dose and subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated. Patients assigned to Cohort II will receive pre-chemotherapy rhTPO at 3.6 μg/kg/dose on Days -5, -3, -1, and post-chemotherapy rhTPO on Days +4, +6, and +8 (6 doses total. Subsequent courses of chemotherapy will begin as soon as the ANC recovers to
≥ 1,000/μL and the platelet count to ≥ 100,000/μL between days 21 and 35. Therapy will continue for maximum six courses. Pharmacokinetic data will be obtained (during course one nly). For the second cohort, full data collection will occur for cycles one and two and limited data collection for cycles 3, 4, 5, and 6.
recombinant human thrombopoietin
carboplatin
etoposide
ifosfamide
G-CSF
Interventions
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recombinant human thrombopoietin
carboplatin
etoposide
ifosfamide
G-CSF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
failed or relapsed after standard first-line antineoplastic therapy
* Sarcoma (soft tissue and bone)
* Kidney tumors
* Brain tumors
* Other solid tumors (gonadal and germ cell tumors, malignant melanoma,
* retinoblastoma, liver tumors, and miscellaneous tumors) Must have had recurrence within the past 4 weeks
No bone marrow involvement
No prior or concurrent myelogenous leukemia
PATIENT CHARACTERISTICS:
Age:
* 1 to 21
Performance status:
* Lansky or Karnofsky 60-100%
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1000/mm3
* Platelet count greater than 100,000/mm3
* No grade III or IV thrombosis
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT less than 2.5 times ULN
Renal:
* Creatinine clearance or glomerular filtration rate at least 70 mL/min
Cardiovascular:
* Ejection fraction normal
* No evidence of arrhythmias requiring therapy
* Fractional shortening greater than 28%
Other:
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 10 days since prior colony-stimulating factor therapy and recovered
* At least 30 days since prior epoetin alfa
* No other concurrent cytokines, including epoetin alfa
Chemotherapy:
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and
* recovered
* At least 3 months since therapy with etoposide, carboplatin, or ifosfamide
* that is identical to study treatment
Endocrine therapy:
* Not specified
Radiotherapy:
* Concurrent radiotherapy allowed after third course of therapy
* No prior cranial/spinal radiotherapy
* No prior radiotherapy to greater than 50% of bone marrow
Surgery:
* Concurrent surgery allowed after the second course of therapy
Other:
* No concurrent investigational agents
* No concurrent lithium, aspirin, coumadin, or heparin
1 Year
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Mitchell S. Cairo, MD
Role: STUDY_CHAIR
Herbert Irving Comprehensive Cancer Center
Locations
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Long Beach Memorial Medical Center
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Beckman Research Institute, City of Hope
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, United States
Kaplan Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Countries
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References
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Angiolillo AL, Davenport V, Bonilla MA, van de Ven C, Ayello J, Militano O, Miller LL, Krailo M, Reaman G, Cairo MS; Children's Oncology Group. A phase I clinical, pharmacologic, and biologic study of thrombopoietin and granulocyte colony-stimulating factor in children receiving ifosfamide, carboplatin, and etoposide chemotherapy for recurrent or refractory solid tumors: a Children's Oncology Group experience. Clin Cancer Res. 2005 Apr 1;11(7):2644-50. doi: 10.1158/1078-0432.CCR-04-1959.
Angiolillo A, Krailo M, Davenport V, et al.: A phase I study of thrombopoietin (rhTPO) + G-CSF in children receiving ifosfamide, carboplatin and etoposide (ICE) chemotherapy for recurrent or refractory solid tumors: a Children's Cancer Group (CCG) study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1511, 2001.
Other Identifiers
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CCG-09717
Identifier Type: -
Identifier Source: secondary_id
CDR0000066668
Identifier Type: -
Identifier Source: secondary_id
09717
Identifier Type: -
Identifier Source: org_study_id
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