drugset / Trial / NCT00003597
Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
Non-randomizedSingle-groupOpen-labelSupportive care
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.
Timeline
- Start
- 1998-11
- Primary completion
- 2004-10
- Completion
- 2005-09
Publications
- Results 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. doi: 10.1158/1078-0432.CCR-04-1959.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | recombinant human thrombopoietin | Protein / enzyme biologic | 1.2 ug/kg | Intravenous |
| Subject | recombinant human thrombopoietin | Protein / enzyme biologic | 2.4 ug/kg | Intravenous |
| Subject | recombinant human thrombopoietin | Protein / enzyme biologic | 3.6 ug/kg | Intravenous |
| Background | Carboplatin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Background | G-CSF | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Background | Ifosfamide | Small molecule | 1800 mg/m2 | Intravenous |