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Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors

23 juli 2014 uppdaterad av: Children's Oncology Group

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

16

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
    • Western Australia
      • Perth, Western Australia, Australien, 6001
        • Princess Margaret Hospital for Children
  • Förenta staterna
    • California
      • Long Beach, California, Förenta staterna, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, Förenta staterna, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Förenta staterna, 91010
        • Beckman Research Institute, City of Hope
      • Los Angeles, California, Förenta staterna, 90027-0700
        • Children's Hospital Los Angeles
      • Orange, California, Förenta staterna, 92668
        • Children's Hospital of Orange County
      • San Francisco, California, Förenta staterna, 94115-0128
        • UCSF Cancer Center and Cancer Research Institute
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20010-2970
        • Children's National Medical Center
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202-5265
        • Indiana University Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109-0752
        • University Of Michigan Comprehensive Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55455
        • University of Minnesota Cancer Center
      • Rochester, Minnesota, Förenta staterna, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 64108
        • Children's Mercy Hospital - Kansas City
    • New York
      • New York, New York, Förenta staterna, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Förenta staterna, 10016
        • Kaplan Cancer Center
      • New York, New York, Förenta staterna, 10032
        • Herbert Irving Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45229-3039
        • Children's Hospital Medical Center - Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • Children's Hospital of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232-6838
        • Vanderbilt Cancer Center
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • University of Texas - MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84132
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, Förenta staterna, 98105
        • Children's Hospital and Regional Medical Center - Seattle
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53792
        • University of Wisconsin Comprehensive Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 år till 21 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Läkemedel: karboplatin
Andra namn:
  • CBDCA
  • Paraplatin
  • NSC #241240
Läkemedel: etoposid
Andra namn:
  • VP-16
  • VePesid
  • NSC #141540
Läkemedel: ifosfamid
Andra namn:
  • IFX
  • NSC #109724
  • IFOS
  • IND #7887
Biologisk: rekombinant humant trombopoietin
Andra namn:
  • RhTPO
  • BB-IND # 7431)
Biologisk: G-CSF
Andra namn:
  • Filgrastim
  • r-metHuG-CSF
  • NSC #614629
  • Neupogen®
  • GRANULOCYT KOLONISTIMULERANDE FAKTOR
Experimentell: 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.
Läkemedel: karboplatin
Andra namn:
  • CBDCA
  • Paraplatin
  • NSC #241240
Läkemedel: etoposid
Andra namn:
  • VP-16
  • VePesid
  • NSC #141540
Läkemedel: ifosfamid
Andra namn:
  • IFX
  • NSC #109724
  • IFOS
  • IND #7887
Biologisk: rekombinant humant trombopoietin
Andra namn:
  • RhTPO
  • BB-IND # 7431)
Biologisk: G-CSF
Andra namn:
  • Filgrastim
  • r-metHuG-CSF
  • NSC #614629
  • Neupogen®
  • GRANULOCYT KOLONISTIMULERANDE FAKTOR

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO)
Tidsram: length of study
To determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO) in children receiving I.C.E. myelosuppressive chemotherapy.
length of study

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Evaluate the time for patients to demonstrate platelet recovery
Tidsram: Length of study
To evaluate the time for patients to demonstrate platelet recovery following I.C.E. chemotherapy with rhTPO + G-CSF.
Length of study

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Children's Oncology Group

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Studiestol: Mitchell S. Cairo, MD, Herbert Irving Comprehensive Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 1998

Primärt slutförande (Faktisk)

1 oktober 2004

Avslutad studie (Faktisk)

1 september 2005

Studieregistreringsdatum

Först inskickad

1 november 1999

Först inskickad som uppfyllde QC-kriterierna

17 april 2003

Första postat (Uppskatta)

18 april 2003

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 juli 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juli 2014

Senast verifierad

1 juli 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 09717
  • CCG-09717
  • CDR0000066668

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