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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


Phase 1
1 Year
21 Years
Open (Enrolling)
Both
Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Mitchell S. Cairo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066668

NCT ID:

NCT00003597

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Cancer
  • 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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Kaplan Cancer CenterNew York, New York  10016
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Beckman Research Institute, City of HopeLos Angeles, California  91010
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Children's Mercy Hospital - Kansas CityKansas City, Missouri  64108