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
recombinant human thrombopoietin
+ carboplatin
+ etoposide
Urogenital Diseases+77
+ Genital Diseases
+ Cytopenia
Supportive Care Study
Summary
Study start date: November 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.16 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 to 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 24 locations
Long Beach Memorial Medical Center
Long Beach, United StatesOpen Long Beach Memorial Medical Center in Google MapsChildren's Hospital Los Angeles
Los Angeles, United StatesJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesBeckman Research Institute, City of Hope
Los Angeles, United States