Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
NCT ID: NCT00003141
Last Updated: 2014-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
94 participants
INTERVENTIONAL
1998-03-31
2011-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (combination chemotherapy, PBSC transplant)
Pts 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.
filgrastim
Given IV
carboplatin
Given IV
cisplatin
Given IV
cyclophosphamide
Given IV
etoposide
Given IV
thiotepa
Given IV
vincristine sulfate
Given IV
conventional surgery
peripheral blood stem cell transplantation
Interventions
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filgrastim
Given IV
carboplatin
Given IV
cisplatin
Given IV
cyclophosphamide
Given IV
etoposide
Given IV
thiotepa
Given IV
vincristine sulfate
Given IV
conventional surgery
peripheral blood stem cell transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
2 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Bruce H. Cohen, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital and Research Center Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Hospitals and Clinics of Minnesota - St. Paul
Saint Paul, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States
Overlook Hospital
Morristown, New Jersey, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
Winthrop University Hospital
Mineola, New York, United States
Beth Israel Medical Center - Petrie Division
New York, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's - Dayton
Dayton, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Penn State Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Mary Bridge Children's Hospital and Health Center - Tacoma
Tacoma, Washington, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Countries
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Other Identifiers
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COG-99703
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-99703
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000065924
Identifier Type: OTHER
Identifier Source: secondary_id
99703
Identifier Type: -
Identifier Source: org_study_id
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