A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors
N/A
2 Years
Both
Brain Tumors, Central Nervous System Tumors, Neuroblastoma, Sarcoma
Trial Information
A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility
Outcome Description:
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
Outcome Time Frame:
Up to 4 weeks after completion of study treatment
Safety Issue:
Yes
Principal Investigator
Bruce H. Cohen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Federal Government
Study ID:
99703
NCT ID:
NCT00003141
Start Date:
March 1998
Completion Date:
October 2011
Related Keywords:
- Brain Tumors
- Central Nervous System Tumors
- Neuroblastoma
- Sarcoma
- 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
- childhood central nervous system embryonal tumor
- childhood central nervous system germinoma
- childhood central nervous system mixed germ cell tumor
- childhood central nervous system teratoma
- childhood central nervous system yolk sac tumor
- Brain Neoplasms
- Nervous System Neoplasms
- Neuroblastoma
- Spinal Cord Neoplasms
- Central Nervous System Neoplasms
- Sarcoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington, Connecticut 06360-2875 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| Deaconess Medical Center | Spokane, Washington 99210-0248 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Children's Hospital Central California | Madera, California 93638-8762 |
| Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
| Covenant Children's Hospital | Lubbock, Texas 79410 |
| Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
| Overlook Hospital | Summit, New Jersey 07902-0220 |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
| Winthrop University Hospital | Mineola, New York 11501 |
| Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
| Rainbow Babies and Children's Hospital | Cleveland, Ohio 44106-5000 |
| Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo, Texas 79106 |
| Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
| Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| 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 |
| Childrens Hospital Los Angeles | Los Angeles, California 90027 |
| Children's Hospital and Research Center Oakland | Oakland, California 94609 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Children's Hospital Center for Cancer and Blood Disorders | Aurora, Colorado 80045 |
| Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
| 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 |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| 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 49503-2560 |
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
| Children's Hospitals and Clinics of Minnesota - St. Paul | St. Paul, Minnesota 55102-2392 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Beth Israel Medical Center - Petrie Division | New York, New York 10003-3803 |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
| Akron Children's Hospital | Akron, Ohio 44308-1062 |
| Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
| Dayton Children's - Dayton | Dayton, Ohio 45404-1815 |
| Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
| Penn State Children's Hospital | Hershey, Pennsylvania 17033-0850 |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
| Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma, Washington 98405 |
