Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Biological: filgrastim Biological: recombinant human thrombopoietin Drug: carboplatin Drug: etoposide Drug: ifosfamide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | 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 |
| Estimated Enrollment: | 24 |
| Study Start Date: | November 1998 |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 24 Study Locations| Study Chair: | Mitchell S. Cairo, MD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003597 History of Changes |
| Other Study ID Numbers: | CDR0000066668, CCG-09717 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Etoposide Etoposide phosphate Isophosphamide mustard Ifosfamide Carboplatin Lenograstim Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013