Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
Condition: Cancer
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

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.
    

Intervention name(s): recombinant human thrombopoietin; carboplatin; etoposide; ifosfamide; G-CSF
Intervention type(s): Biological; Drug; Drug; Drug; Biological
Other intervention name(s): RhTPO; BB-IND # 7431); Paraplatin; CBDCA; NSC #241240; VP-16; VePesid; NSC #141540; IFX; IFOS; NSC #109724; IND #7887; GRANULOCYTE COLONY-STIMULATING FACTOR; r-metHuG-CSF; Filgrastim; Neupogen®; NSC #614629
Intervention MeSH terms: Carboplatin; Etoposide; Ifosfamide; Lenograstim
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: 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