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Busulfan in Treating Children and Adolescents With Refractory CNS Cancer

This study has been completed.

Sponsors and Collaborators: Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006246
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of intrathecal busulfan in treating children and adolescents who have refractory CNS cancer.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Leukemia
Lymphoma
Metastatic Cancer
Retinoblastoma
Sarcoma
Drug: busulfan
Phase I

Genetics Home Reference related topics:   retinoblastoma   

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Meningitis    Soft Tissue Sarcoma   

Drug Information available for:   Busulfan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study of Intrathecal Spartaject-Busulfan in Children With Neoplastic Meningitis

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   November 2000

Detailed Description:

OBJECTIVES:

  • Determine the qualitative and quantitative toxicities of intrathecally administered busulfan in children and adolescents with refractory CNS malignancies.
  • Determine the maximum tolerated dose of this treatment regimen in these patients.
  • Determine the cerebrospinal fluid and serum pharmacokinetics of this treatment regimen in these patients.
  • Determine the efficacy of this treatment regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive intrathecal busulfan twice a week, at least 3 days apart, for 2 weeks. Patients with complete or partial response or stable disease may continue therapy once a week for 2 weeks, once a week every other week for 2 treatments, and then once a month thereafter in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of busulfan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed every 3 months for the first year, every 6 months for 4 years, and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study over 18-38 months.

  Eligibility
Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed CNS malignancy, including any of the following:

    • Primary malignant brain tumor refractory to standard therapy and metastatic to the cerebrospinal fluid (CSF) or leptomeningeal subarachnoid space
    • Recurrent or persistent leptomeningeal leukemia, lymphoma, or germ cell tumor refractory to conventional therapy

      • In second or greater relapse
      • CSF white blood count greater than 5 cells/mm3 with blasts on cytospin OR
      • Evidence of leptomeningeal tumor by MRI
  • No concurrent bone marrow disease
  • No obstruction or compartmentalization of CSF flow on CSF flow study

PATIENT CHARACTERISTICS:

Age:

  • 3 to 21

Performance status:

  • Lansky 50-100% (under 10 years)
  • Karnofsky 50-100% (10 to 21 years)

Life expectancy:

  • Greater than 8 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 75,000/mm^3

Hepatic:

  • Bilirubin normal for age
  • ALT and AST less than 5 times upper limit of normal (ULN)
  • No hepatic disease

Renal:

  • Creatinine no greater than 1.5 times ULN OR
  • Glomerular filtration rate greater than 70 mL/min
  • No renal disease

Cardiovascular:

  • No cardiac disease

Pulmonary:

  • No pulmonary disease

Other:

  • No uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
  • At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine) and recovered
  • Evidence of subsequent disease progression
  • Concurrent systemic chemotherapy allowed for recurrent disease after first course of treatment except for the following:

    • Chemotherapy targeted at leptomeningeal disease
    • Other phase I agent
    • Any agent that significantly penetrates the CSF (e.g., high dose methotrexate greater than 1 g/m2, thiotepa, high dose cytarabine, fluorouracil, IV mercaptopurine, nitrosoureas, or topotecan)
    • Any agent that causes serious unpredictable CNS side effects

Endocrine therapy:

  • Prior dexamethasone allowed with decreasing or stable dose at least one week before study
  • Concurrent dexamethasone or prednisone with chemotherapy regimen allowed

Radiotherapy:

  • At least 1 week since prior focal irradiation to the brain or spine
  • At least 8 weeks since prior craniospinal irradiation
  • No concurrent cranial or craniospinal irradiation

Surgery:

  • Not specified

Other:

  • No other concurrent intrathecal or systemic therapy for leptomeningeal disease
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006246

Locations
United States, California
UCSF Cancer Center and Cancer Research Institute    
      San Francisco, California, United States, 94143-0128
United States, District of Columbia
Children's National Medical Center    
      Washington, District of Columbia, United States, 20010-2970
United States, Massachusetts
Dana-Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710
United States, Pennsylvania
Children's Hospital of Philadelphia    
      Philadelphia, Pennsylvania, United States, 19104-4318
Children's Hospital of Pittsburgh    
      Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Saint Jude Children's Research Hospital    
      Memphis, Tennessee, United States, 38105-2794
United States, Texas
Baylor College of Medicine    
      Houston, Texas, United States, 77030
United States, Washington
Children's Hospital and Regional Medical Center - Seattle    
      Seattle, Washington, United States, 98105

Sponsors and Collaborators
Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)

Investigators
Study Chair:     Sri Gururangan, MD     Duke University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068178, PBTC-004
First Received:   September 11, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006246
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia  
childhood infratentorial ependymoma  
recurrent childhood rhabdomyosarcoma  
recurrent childhood brain tumor  
recurrent retinoblastoma  
recurrent childhood lymphoblastic lymphoma  
childhood central nervous system germ cell tumor  
recurrent childhood acute myeloid leukemia  
recurrent/refractory childhood Hodgkin lymphoma  
leptomeningeal metastases  
childhood high-grade cerebral astrocytoma  
childhood oligodendroglioma  
childhood choroid plexus tumor  
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
recurrent childhood large cell lymphoma
recurrent childhood brain stem glioma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood ependymoma
recurrent childhood malignant germ cell tumor

Study placed in the following topic categories:
Retinal Neoplasms
Choroid Plexus Neoplasms
Leukemia, Lymphoid
Hodgkin's disease
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Central Nervous System Neoplasms
Leukemia, Myeloid, Acute
Retinoblastoma
Soft tissue sarcomas
Ependymoma
Meningitis
Lymphoma, large-cell
Leukemia
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neuroepithelioma
Meningioma
Glioma
Choroid Plexus neoplasms
Acute myelocytic leukemia
Hodgkin Disease
Lymphoma
Retinal Diseases
Nervous System Neoplasms
Rhabdomyosarcoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Eye Neoplasms

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents

ClinicalTrials.gov processed this record on December 03, 2008




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