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Brain TumorsPhase 1NCT00003141

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors

A Phase 1 study testing filgrastim, carboplatin and cisplatin in people with Brain Tumors and Central Nervous System Tumors, run by Children's Oncology Group at 71 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study

Who is it for?
Ages Up to 2 years
What is being tested?
filgrastim, carboplatin and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
71 sitesin 3 countries
Study dates
Mar 1998to Oct 2011
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 Up to 2 years
  • All sexes
  • No healthy volunteers
  • Child

DISEASE CHARACTERISTICS:

  • Histologically proven malignant brain or spinal cord tumor, including the following:
  • Primitive neuroectodermal tumor
  • Ganglioneuroblastoma
  • Medulloblastoma neuroblastoma
  • Desmoplastic medulloblastoma
  • Medulloepithelioma
  • Ependymoma neuroepithelioma
  • Anaplastic ependymoma germ cell tumor
  • Astrocytoma germinoma
  • Anaplastic astrocytoma
  • Embryonal carcinoma
  • Glioblastoma endodermal sinus tumor
  • Gliosarcoma malignant teratoma
  • Choroid plexus carcinoma
  • Mixed germ cell tumor
  • Cerebellar sarcoma
  • Pineoblastoma
  • Atypical teratoid/rhabdoid tumor
  • Choriocarcinoma
  • Teratoma (malignant or with malignant transformations)
  • Diffusely involved brain stem tumors allowed if there is evidence of brain stem glioma by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

  • 6 months to less than 3 years

Performance Status:

  • Not specified

Life Expectancy:

  • More than 8 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL

Renal:

  • Glomerular filtration rate or creatinine clearance greater than 70 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroids allowed

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • No more than 6 weeks since prior surgery
  • Recovered from prior surgery (stable)

Trial locations and contacts

71 sites in 3 countries.

71 sites in 3 countries

United States66 sites

  • Akron Children's Hospital

    Akron, Ohio, 44308-1062

  • Texas Tech University Health Sciences Center School of Medicine - Amarillo

    Amarillo, Texas, 79106

  • C.S. Mott Children's Hospital at University of Michigan Medical Center

    Ann Arbor, Michigan, 48109-0286

  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

    Atlanta, Georgia, 30322

  • MBCCOP - Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912-3730

  • Children's Hospital Center for Cancer and Blood Disorders

    Aurora, Colorado, 80045

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106-5000

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205-2696

  • Dayton Children's - Dayton

    Dayton, Ohio, 45404-1815

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

    Farmington, Connecticut, 06360-2875

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503-2560

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033-0850

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-5381

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89109-2306

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048-1865

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • Kosair Children's Hospital

    Louisville, Kentucky, 40232

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455

  • Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Overlook Hospital

    Morristown, New Jersey, 07962

  • Beth Israel Medical Center - Petrie Division

    New York, New York, 10003-3803

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507-1971

  • Children's Hospital and Research Center Oakland

    Oakland, California, 94609

  • Children's Hospital of Orange County

    Orange, California, 92868

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-9786

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Kaiser Permanente Medical Center - Oakland

    Sacramento, California, 95825

  • Children's Hospitals and Clinics of Minnesota - St. Paul

    Saint Paul, Minnesota, 55102-2392

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113-1100

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229-3993

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • Mary Bridge Children's Hospital and Health Center - Tacoma

    Tacoma, Washington, 98405

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Children's National Medical Center

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

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19803

Other trials in United States

Canada4 sites

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Children's & Women's Hospital of British Columbia

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia1 site

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

Other trials in Australia

About this study

Official title: A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of thiotepa in infants with malignant brain or spinal cord tumors receiving intensive chemotherapy.
  • Determine the feasibility and toxicity of intensive chemotherapy with peripheral blood stem cell (PBSC) rescue in these patients.
  • Assess the feasibility of harvesting PBSCs in these patients.
  • Determine the complete response rate and overall event-free survival rate in patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

Patients undergo surgery for diagnosis and maximal tumor resection.

Within 6 weeks of surgery or when stable, patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; cyclophosphamide IV over 1 hour on days 1-2; and etoposide IV over 1 hour on days 0-2. Twenty four hours after the last cyclophosphamide dose, patients receive filgrastim (G-CSF) subcutaneously (SC) and undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Within 6 weeks after induction chemotherapy, patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours. Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose. Patients receive G-CSF SC daily on days 3 to 21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study.

Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 3 years, and then annually for 3 years or until relapse.

PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1 year.

Keywords
childhood infratentorial ependymoma, childhood supratentorial ependymoma, disseminated neuroblastoma, stage 4S neuroblastoma, embryonal childhood rhabdomyosarcoma, childhood high-grade cerebral astrocytoma, childhood choroid plexus tumor, previously untreated childhood rhabdomyosarcoma, untreated childhood brain stem glioma, untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood cerebellar astrocytoma, untreated childhood medulloblastoma, newly diagnosed childhood ependymoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma, childhood spinal cord neoplasm, childhood atypical teratoid/rhabdoid tumor, childhood low-grade cerebral astrocytoma, childhood central nervous system choriocarcinoma
Medical subject headings
Brain Neoplasms, Central Nervous System Neoplasms, Neuroblastoma, Sarcoma, Astrocytoma, Choroid Plexus Neoplasms, Spinal Cord Neoplasms, Rhabdoid Tumor

What participants receive

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

Study groups in NCT00003141
Study groupRoleWhat they receive
Treatment (combination chemotherapy, PBSC transplant)ExperimentalPts undergo conventional surgery for diagnosis \& max tumor resection. In 6 wks of surgery or when stable pts begin induction chemotherapy(cisplatin IV over 6 hrs on day 0; vincristine sulfate IV on days 0,7,14; cyclophosphamide IV over 1 hr on days 1-2; and etoposide IV over 1 hr on days 0-2. 24 hrs after the last cyclophosphamide dose, pts receive filgrastim (G-CSF) \& undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 crs. Within 6 wks after induction, pts receive consolidation (carboplatin IV over 2 hrs on days 0-1 next esc. doses of thiotepa IV over 2 hrs. Pts undergo peripheral blood stem cell transplantation 48 hrs after last thiotepa dose. Pts receive G-CSF SC daily on days 3-21. Treatment repeats every 21 days for up to 3 crs. Pts with dose-limiting toxicity due to thiotepa are removed from study. Pts are followed at 4 wks, 3 mths for 1 yr, 6 mths for 3 yrs, annually for 3 yrs or until relapse.
Receives: Biological: filgrastim; Drug: carboplatin; Drug: cisplatin; Drug: cyclophosphamide; Drug: etoposide; Drug: thiotepa; Drug: vincristine sulfate; Procedure: conventional surgery; Procedure: peripheral blood stem cell transplantation

What is being measured

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

  1. Feasibility

    Demonstrate the feasibility of administering this regimen, to select an acceptable Thiotepa dose for Consolidation therapy, and to document significant toxicities and estimate their overall rates

    Measured: Up to 4 weeks after completion of study treatment

  2. Maximal tolerated dose of thiotepa for consolidation therapy

    The dose level will be assigned within 3 working days prior to beginning Consolidation.

    Measured: 9 weeks

  3. Overall rates of significant toxicities including grade IV ototoxicity, electrolytic wasting (grade IV), and hemorrhagic cystitis (grade IV)

    Estimates will be obtained using life-table methods with an event defined as the first occurrence of toxicity. Graded using the CCG Toxicity and Complications Criteria.

    Measured: Up to 6 years

Secondary outcomes (1)

  1. Event Free Survival

    Measured: From the time of study entry to the first occurrence of death by any cause, progression or recurrence of disease or occurrence of a second malignant neoplasm, assessed up

Timeline

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

  1. First posted6 Nov 2003 (estimated)
  2. Study startMar 1998
  3. Primary completionDec 2007
  4. Study completionOct 2011

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003141
Sponsor's protocol ID
99703
Other IDs
COG-99703, CCG-99703, CDR0000065924
Status last verified
Mar 2014
First submitted
1 Nov 1999
Last updated
28 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing filgrastim, carboplatin and cisplatin in people with Brain Tumors and Central Nervous System Tumors, run by Children's Oncology Group at 71 sites in 3 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 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Canada, 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?

Feasibility (time frame: Up to 4 weeks after completion of study treatment). The study lists 3 primary outcomes in all. 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 NCT00003141.

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 28 Mar 2014.

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