A Phase I Study of Thrombopoietin (rhTPO) Plus G-CSF in Children Receiving Ifosfamide, Carboplatin, and Etoposide (I.C.E.) Chemotherapy for Recurrent or Refractory Solid Tumors
- 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
- 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
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.
Primary Purpose: Supportive Care
Mitchell S. Cairo, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Kaplan Cancer Center||New York, New York 10016|
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|Vanderbilt Cancer Center||Nashville, Tennessee 37232-6838|
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|Beckman Research Institute, City of Hope||Los Angeles, California 91010|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|
|Long Beach Memorial Medical Center||Long Beach, California 90806|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Children's Hospital of Orange County||Orange, California 92668|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Children's Hospital Medical Center - Cincinnati||Cincinnati, Ohio 45229-3039|
|Children's Hospital of Pittsburgh||Pittsburgh, Pennsylvania 15213|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|
|Children's Mercy Hospital - Kansas City||Kansas City, Missouri 64108|