Full Text View
Tabular View
No Study Results Posted
Related Studies
Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Children's Cancer Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003597
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

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.


Condition Intervention Phase
Cancer
Biological: filgrastim
Biological: recombinant human thrombopoietin
Drug: carboplatin
Drug: etoposide
Drug: ifosfamide
Phase I

Study Type: Interventional
Study Design: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 24
Study Start Date: November 1998
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven (except for brain stem tumors) malignancy that has

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003597

  Hide Study Locations
Locations
United States, California
Beckman Research Institute, City of Hope
Los Angeles, California, United States, 91010
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Children's Hospital of Orange County
Orange, California, United States, 92668
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, United States, 64108
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Kaplan Cancer Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
Children's Cancer Group
Investigators
Study Chair: Mitchell S. Cairo, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
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.
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.

Study ID Numbers: CDR0000066668, CCG-09717
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003597     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood rhabdomyosarcoma
recurrent renal cell cancer
recurrent neuroblastoma
recurrent childhood liver cancer
recurrent Wilms tumor and other childhood kidney tumors
recurrent retinoblastoma
childhood central nervous system germ cell tumor
recurrent osteosarcoma
recurrent gestational trophoblastic tumor
recurrent malignant testicular germ cell tumor
recurrent intraocular melanoma
recurrent melanoma
unspecified childhood solid tumor, protocol specific
childhood germ cell tumor
recurrent childhood soft tissue sarcoma
recurrent ovarian germ cell tumor
extragonadal germ cell tumor
recurrent uterine sarcoma
neutropenia
thrombocytopenia
recurrent childhood brain stem glioma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood visual pathway glioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Ifosfamide
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Carboplatin
Alkylating Agents
Antineoplastic Agents, Phytogenic
Etoposide phosphate
Etoposide
Pharmacologic Actions
Isophosphamide mustard

ClinicalTrials.gov processed this record on November 22, 2009