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- Klinische proef 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
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Western Australia
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Perth, Western Australia, Australië, 6001
- Princess Margaret Hospital for Children
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California
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Long Beach, California, Verenigde Staten, 90806
- Long Beach Memorial Medical Center
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Los Angeles, California, Verenigde Staten, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Verenigde Staten, 91010
- Beckman Research Institute, City of Hope
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Los Angeles, California, Verenigde Staten, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, Verenigde Staten, 92668
- Children's Hospital of Orange County
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San Francisco, California, Verenigde Staten, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20010-2970
- Children's National Medical Center
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202-5265
- Indiana University Cancer Center
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic Cancer Center
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64108
- Children's Mercy Hospital - Kansas City
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New York
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Verenigde Staten, 10016
- Kaplan Cancer Center
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New York, New York, Verenigde Staten, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- Children's Hospital of Pittsburgh
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37232-6838
- Vanderbilt Cancer Center
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Texas
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Houston, Texas, Verenigde Staten, 77030
- University of Texas - MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84132
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Verenigde Staten, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53792
- University of Wisconsin Comprehensive Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Cohort 1
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).
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Experimenteel: Cohort 2
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. |
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO)
Tijdsspanne: length of study
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To determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO) in children receiving I.C.E.
myelosuppressive chemotherapy.
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length of study
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Evaluate the time for patients to demonstrate platelet recovery
Tijdsspanne: Length of study
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To evaluate the time for patients to demonstrate platelet recovery following I.C.E.
chemotherapy with rhTPO + G-CSF.
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Length of study
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Mitchell S. Cairo, MD, Herbert Irving Comprehensive Cancer Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- recidiverende niercelkanker
- niet-gespecificeerde solide kindertumor, protocolspecifiek
- neutropenie
- terugkerend melanoom
- recidiverend intraoculair melanoom
- trombocytopenie
- recidiverende kinderrabdomyosarcoom
- recidiverend neuroblastoom
- recidiverend baarmoedersarcoom
- recidiverende ovariumkiemceltumor
- terugkerende kwaadaardige testiculaire kiemceltumor
- recidiverend Ewing-sarcoom / perifere primitieve neuro-ectodermale tumor
- recidiverend osteosarcoom
- terugkerende Wilms-tumor en andere niertumoren bij kinderen
- terugkerende kinder supratentoriale primitieve neuroectodermale tumor
- recidiverend cerebellair astrocytoom bij kinderen
- recidiverend cerebraal astrocytoom bij kinderen
- extragonadale kiemceltumor
- terugkerende leverkanker bij kinderen
- recidiverend wekedelensarcoom bij kinderen
- recidiverend hersenstamglioom bij kinderen
- recidiverend medulloblastoom bij kinderen
- kiemceltumor van het centrale zenuwstelsel in de kindertijd
- kinderkiemceltumor
- recidiverend retinoblastoom
- terugkerende trofoblasttumor tijdens de zwangerschap
- recidiverend glioom van de visuele baan in de kindertijd
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekte attributen
- Herhaling
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Immunologische factoren
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Antineoplastische middelen, fytogeen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Adjuvantia, immunologisch
- Carboplatine
- Etoposide
- Ifosfamide
- Lenograstim
Andere studie-ID-nummers
- 09717
- CCG-09717
- CDR0000066668
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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