Clinical trial · Interventional
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
NCT00003597CI-TRIAL-00015179completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Biological | — | UNRESOLVED |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| recombinant human thrombopoietin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5. All patients receive recombinant human thrombopoietin (rhTPO). rhTPO began on the last day of ICE (Ifosfamide, Carboplatin and Etoposide) chemotherapy (Day 4) and subsequent doses will be administered on Days 6, 8, 10 and 12 (5 doses total). The initial dose of rhTPO was 1.2 μg/kg/dose and was subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated. Therapy will continue for maximum six courses. Pharmacokinetic data will be obtained (during course one only).
- interventionNames
- Biological: recombinant human thrombopoietin
- Drug: carboplatin
- Drug: etoposide
- Drug: ifosfamide
- Biological: G-CSF
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5. All patients receive recombinant human thrombopoietin (rhTPO). The dose of rhTPO 1.2 μg/kg/dose and subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated. Patients assigned to Cohort II will receive pre-chemotherapy rhTPO at 3.6 μg/kg/dose on Days -5, -3, -1, and post-chemotherapy rhTPO on Days +4, +6, and +8 (6 doses total. Subsequent courses of chemotherapy will begin as soon as the ANC recovers to ≥ 1,000/μL and the platelet count to ≥ 100,000/μL between days 21 and 35. Therapy will continue for maximum six courses. Pharmacokinetic data will be obtained (during course one nly). For the second cohort, full data collection will occur for cycles one and two and limited data collection for cycles 3, 4, 5, and 6.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTAngiolillo 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. PMID 15814645
- RESULTAngiolillo 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.