NCT00003597

Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	recombinant human thrombopoietin
DRUG	carboplatin
DRUG	etoposide
DRUG	ifosfamide
BIOLOGICAL	G-CSF

Timeline

• Start date: 1998-11-01
• Primary completion: 2004-10-01
• Completion: 2005-09-01
• First posted: 2003-04-18
• Last updated: 2014-07-24

Locations

24 sites across 2 countries: United States, Australia