cropped color_logo_with_background.png

Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 2 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00003141
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Children's Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Bruce H. Cohen, MD
Principal Investigator Affiliation The Cleveland Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries Australia, Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain Tumors, Central Nervous System Tumors, Neuroblastoma, Sarcoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Biological: - filgrastim

Given IV

Drug: - carboplatin

Given IV

Drug: - cisplatin

Given IV

Drug: - cyclophosphamide

Given IV

Drug: - etoposide

Given IV

Drug: - thiotepa

Given IV

Drug: - vincristine sulfate

Given IV

Procedure: - conventional surgery

Procedure: - peripheral blood stem cell transplantation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope Comprehensive Cancer Center, Duarte, California

Status

Address

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000

Childrens Hospital Los Angeles, Los Angeles, California

Status

Address

Childrens Hospital Los Angeles

Los Angeles, California, 90027

Los Angeles, California

Status

Address

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048-1865

Los Angeles, California

Status

Address

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781

Children's Hospital Central California, Madera, California

Status

Address

Children's Hospital Central California

Madera, California, 93638-8762

Oakland, California

Status

Address

Children's Hospital and Research Center Oakland

Oakland, California, 94609

Children's Hospital of Orange County, Orange, California

Status

Address

Children's Hospital of Orange County

Orange, California, 92868

Sacramento, California

Status

Address

Kaiser Permanente Medical Center - Oakland

Sacramento, California, 95825

San Francisco, California

Status

Address

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115

Aurora, Colorado

Status

Address

Children's Hospital Center for Cancer and Blood Disorders

Aurora, Colorado, 80045

Presbyterian - St. Luke's Medical Center, Denver, Colorado

Status

Address

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218

Farmington, Connecticut

Status

Address

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

Farmington, Connecticut, 06360-2875

Alfred I. duPont Hospital for Children, Wilmington, Delaware

Status

Address

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803

Washington, District of Columbia

Status

Address

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington, District of Columbia, 20007

Children's National Medical Center, Washington, District of Columbia

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010-2970

Atlanta, Georgia

Status

Address

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

Atlanta, Georgia, 30322

Augusta, Georgia

Status

Address

MBCCOP - Medical College of Georgia Cancer Center

Augusta, Georgia, 30912-3730

Savannah, Georgia

Status

Address

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

Savannah, Georgia, 31403-3089

Chicago, Illinois

Status

Address

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470

Indianapolis, Indiana

Status

Address

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289

Iowa City, Iowa

Status

Address

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002

Lexington, Kentucky

Status

Address

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093

Kosair Children's Hospital, Louisville, Kentucky

Status

Address

Kosair Children's Hospital

Louisville, Kentucky, 40232

Ann Arbor, Michigan

Status

Address

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

Ann Arbor, Michigan, 48109-0286

Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan

Status

Address

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503-2560

CCOP - Kalamazoo, Kalamazoo, Michigan

Status

Address

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-5381

Minneapolis, Minnesota

Status

Address

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

Minneapolis, Minnesota

Status

Address

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455

Mayo Clinic Cancer Center, Rochester, Minnesota

Status

Address

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905

St. Paul, Minnesota

Status

Address

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

St. Paul, Minnesota, 55102-2392

Children's Mercy Hospital, Kansas City, Missouri

Status

Address

Children's Mercy Hospital

Kansas City, Missouri, 64108

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada

Status

Address

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89109-2306

Morristown, New Jersey

Status

Address

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, 07962

Overlook Hospital, Morristown, New Jersey

Status

Address

Overlook Hospital

Morristown, New Jersey, 07962

St. Joseph's Hospital and Medical Center, Paterson, New Jersey

Status

Address

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503

Bronx, New York

Status

Address

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Bronx, New York, 10461

Winthrop University Hospital, Mineola, New York

Status

Address

Winthrop University Hospital

Mineola, New York, 11501

New York, New York

Status

Address

Beth Israel Medical Center - Petrie Division

New York, New York, 10003-3803

New York, New York

Status

Address

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016

New York, New York

Status

Address

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

Chapel Hill, North Carolina

Status

Address

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

Chapel Hill, North Carolina, 27599-7295

CCOP - MeritCare Hospital, Fargo, North Dakota

Status

Address

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122

Akron Children's Hospital, Akron, Ohio

Status

Address

Akron Children's Hospital

Akron, Ohio, 44308-1062

Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039

Rainbow Babies and Children's Hospital, Cleveland, Ohio

Status

Address

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106-5000

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195

Nationwide Children's Hospital, Columbus, Ohio

Status

Address

Nationwide Children's Hospital

Columbus, Ohio, 43205-2696

Dayton Children's - Dayton, Dayton, Ohio

Status

Address

Dayton Children's - Dayton

Dayton, Ohio, 45404-1815

Medical University of Ohio Cancer Center, Toledo, Ohio

Status

Address

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614

Portland, Oregon

Status

Address

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098

Penn State Children's Hospital, Hershey, Pennsylvania

Status

Address

Penn State Children's Hospital

Hershey, Pennsylvania, 17033-0850

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-9786

Pittsburgh, Pennsylvania

Status

Address

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213

Avera Cancer Institute, Sioux Falls, South Dakota

Status

Address

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

Sioux Falls, South Dakota

Status

Address

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039

Amarillo, Texas

Status

Address

Texas Tech University Health Sciences Center School of Medicine - Amarillo

Amarillo, Texas, 79106

Fort Worth, Texas

Status

Address

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104

Covenant Children's Hospital, Lubbock, Texas

Status

Address

Covenant Children's Hospital

Lubbock, Texas, 79410

San Antonio, Texas

Status

Address

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229-3993

Primary Children's Medical Center, Salt Lake City, Utah

Status

Address

Primary Children's Medical Center

Salt Lake City, Utah, 84113-1100

Norfolk, Virginia

Status

Address

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507-1971

Seattle, Washington

Status

Address

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105

Group Health Central Hospital, Seattle, Washington

Status

Address

Group Health Central Hospital

Seattle, Washington, 98112

Deaconess Medical Center, Spokane, Washington

Status

Address

Deaconess Medical Center

Spokane, Washington, 99210-0248

Tacoma, Washington

Status

Address

Mary Bridge Children's Hospital and Health Center - Tacoma

Tacoma, Washington, 98405

International Sites

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Status

Address

Princess Margaret Hospital for Children

Perth, Western Australia, 6001

Vancouver, British Columbia, Canada

Status

Address

Children's & Women's Hospital of British Columbia

Vancouver, British Columbia, V6H 3V4

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Status

Address

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Address

Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Regina, Saskatchewan, Canada

Status

Address

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1

Powered By