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CancerPhase 1NCT00003597

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

A Phase 1 study testing recombinant human thrombopoietin, carboplatin and etoposide in people with Cancer, run by Children's Oncology Group at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 1 year to 21 years
Conditions the study is for
Cancer
What is being tested?
recombinant human thrombopoietin, carboplatin and etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
24 sitesin 2 countries
Study dates
Nov 1998to Sep 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

United States23 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Children's Hospital Medical Center - Cincinnati

    Cincinnati, Ohio, 45229-3039

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • Children's Mercy Hospital - Kansas City

    Kansas City, Missouri, 64108

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-0700

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Beckman Research Institute, City of Hope

    Los Angeles, California, 91010

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Vanderbilt Cancer Center

    Nashville, Tennessee, 37232-6838

  • Kaplan Cancer Center

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Children's Hospital of Orange County

    Orange, California, 92668

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84132

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

Other trials in United States

Australia1 site

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

Other trials in Australia

About this study

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

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.

Read the detailed description

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.

Conditions
Cancer
Being tested
recombinant human thrombopoietin, carboplatin, etoposide, ifosfamide, G-CSF
Keywords
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
Medical subject headings
Neoplasms, Carcinoma, Renal Cell, Neuroblastoma, Wilms Tumor, Retinoblastoma, Osteosarcoma, Gestational Trophoblastic Disease, Testicular Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant human thrombopoietinBiological

    Also called RhTPO, BB-IND # 7431)

  • carboplatinDrug

    Also called Paraplatin, CBDCA, NSC #241240

  • etoposideDrug

    Also called VP-16, VePesid, NSC #141540

  • ifosfamideDrug

    Also called IFX, IFOS, NSC #109724, IND #7887

  • G-CSFBiological

    Also called GRANULOCYTE COLONY-STIMULATING FACTOR, r-metHuG-CSF, Filgrastim, Neupogen®

Study groups in NCT00003597
Study groupRoleWhat they receive
Cohort 1ExperimentalChemotherapy 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).
Receives: Biological: recombinant human thrombopoietin; Drug: carboplatin; Drug: etoposide; Drug: ifosfamide; Biological: G-CSF
Cohort 2ExperimentalChemotherapy 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.
Receives: Biological: recombinant human thrombopoietin; Drug: carboplatin; Drug: etoposide; Drug: ifosfamide; Biological: G-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO)

    To determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO) in children receiving I.C.E. myelosuppressive chemotherapy.

    Measured: length of study

Secondary outcomes (1)

  1. Evaluate the time for patients to demonstrate platelet recovery

    To evaluate the time for patients to demonstrate platelet recovery following I.C.E. chemotherapy with rhTPO + G-CSF.

    Measured: Length of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2003 (estimated)
  2. Study startNov 1998
  3. Primary completionOct 2004
  4. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003597
Sponsor's protocol ID
09717
Other IDs
CCG-09717, CDR0000066668
Status last verified
Jul 2014
First submitted
1 Nov 1999
Last updated
24 Jul 2014
Results posted
No

Publications

  • Angiolillo 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.

    PubMed 15814645

  • Angiolillo 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing recombinant human thrombopoietin, carboplatin and etoposide in people with Cancer, run by Children's Oncology Group at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO) (time frame: length of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003597, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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