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


Phase 1
N/A
2 Years
Not Enrolling
Both
Brain Tumors, Central Nervous System Tumors, Neuroblastoma, Sarcoma

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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 CenterNew York, New York  10021
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
CCOP - MeritCare HospitalFargo, North Dakota  58122
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Avera Cancer InstituteSioux Falls, South Dakota  57105
Deaconess Medical CenterSpokane, Washington  99210-0248
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Children's Hospital Central CaliforniaMadera, California  93638-8762
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Winthrop University HospitalMineola, New York  11501
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Group Health Central HospitalSeattle, Washington  98104
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Childrens Hospital Los AngelesLos Angeles, California  90027
Children's Hospital and Research Center OaklandOakland, California  94609
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Children's Hospital Center for Cancer and Blood DisordersAurora, Colorado  80045
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
Children's Hospitals and Clinics of Minnesota - St. PaulSt. Paul, Minnesota  55102-2392
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Beth Israel Medical Center - Petrie DivisionNew York, New York  10003-3803
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Akron Children's HospitalAkron, Ohio  44308-1062
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Dayton Children's - DaytonDayton, Ohio  45404-1815
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Penn State Children's HospitalHershey, Pennsylvania  17033-0850
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Mary Bridge Children's Hospital and Health Center - TacomaTacoma, Washington  98405