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Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors

This study has been completed.

Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005952
  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 doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Head and Neck Cancer
Kidney Cancer
Neuroblastoma
Ovarian Cancer
Sarcoma
Testicular Germ Cell Tumor
Drug: filgrastim
Drug: temozolomide
Procedure: peripheral blood stem cell transplantation
Phase I
Phase II

MedlinePlus related topics:   Cancer    Head and Neck Cancer    Kidney Cancer    Neuroblastoma    Ovarian Cancer    Soft Tissue Sarcoma    Wilms' Tumor   

ChemIDplus related topics:   Filgrastim    Temozolomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors

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

Primary Outcome Measures:
  • Overall response at 12 months [ Designated as safety issue: No ]
  • Disease-free survival at 12 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months [ Designated as safety issue: Yes ]
  • Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months [ Designated as safety issue: No ]

Estimated Enrollment:   30
Study Start Date:   August 2000

Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors.
  • Evaluate the toxicity of this treatment in these patients.
  • Determine the activity of this treatment in these patients.

OUTLINE: This is a dose escalation study of temozolomide.

Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on day -5 and continuing through at least day 3. Peripheral blood stem cells (PBSC) are collected on days 0, 2, and 4. Patients then receive oral temozolomide daily for 5 consecutive days. PBSC collections are reinfused 1 day after the last dose of temozolomide. Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.

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

Patients are followed every 3 months for 1-3 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.

  Eligibility
Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed malignant glioma or recurrent malignant CNS tumor of any pathology OR
  • Histologically confirmed non-CNS tumor

    • Recurrent soft tissue sarcomas (e.g., rhabdomyosarcoma)
    • Recurrent or resistant neuroblastoma
    • Recurrent Wilm's tumor
    • Recurrent Ewing's sarcoma
    • Recurrent primitive neuroectodermal tumors
    • Recurrent nasopharyngeal carcinoma
    • Recurrent germ cell tumor
  • Expected cure rate less than 10% with standard therapy
  • Measurable and/or active disease
  • History of bone marrow tumor infiltration with or without mass lesions or isolated abnormal CSF cytology as only evidence of recurrent disease allowed if complete response was first achieved with primary conventional therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and under

Performance status:

  • Karnofsky 70-100% OR
  • Lansky 70-100%

Life expectancy:

  • Greater than 8 weeks

Hematopoietic:

  • Reasonably cellular bone marrow (greater than 15% cellularity on biopsy)
  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 75,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • SGPT less than 120 U/L

Renal:

  • Creatinine less than 1.5 mg/dL

Cardiovascular:

  • Systolic fraction or ejection fraction at least 80% predicted for age by echocardiogram

Pulmonary:

  • CVC or DLCO at least 60% predicted for age OR clearance from pulmonologist

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection
  • Able to tolerate vigorous hydration schedule

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent white blood cell transfusion
  • No other concurrent hematopoietic growth factors

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No other concurrent cytotoxic drugs (systemic or intrathecal)

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 1 week since prior radiotherapy

Surgery:

  • At least 1 week since prior surgery

Other:

  • No other concurrent investigational agents
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005952

Locations
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Investigators
Study Chair:     Henry S. Friedman, MD     Duke University    
  More Information


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

Study ID Numbers:   CDR0000067932, DUMC-1735-04-9R5, DUMC-1735-02-9R3, DUMC-1735-01-9R2, DUMC-1833-99-10, NCI-G00-1796
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005952
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood low-grade cerebral astrocytoma  
recurrent childhood rhabdomyosarcoma  
childhood craniopharyngioma  
disseminated neuroblastoma  
stage 4S neuroblastoma  
recurrent neuroblastoma  
stage IV Wilms tumor  
stage V Wilms tumor  
recurrent Wilms tumor and other childhood kidney tumors  
childhood central nervous system germ cell tumor  
stage III malignant testicular germ cell tumor  
recurrent malignant testicular germ cell tumor  
stage IV nasopharyngeal cancer  
recurrent nasopharyngeal cancer  
childhood germ cell tumor  
metastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
childhood high-grade cerebral astrocytoma
childhood oligodendroglioma
childhood choroid plexus tumor
untreated childhood brain stem glioma
recurrent childhood brain stem glioma
untreated childhood supratentorial primitive neuroectodermal tumor
recurrent childhood supratentorial primitive neuroectodermal tumor
untreated childhood cerebellar astrocytoma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
untreated childhood medulloblastoma

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Urogenital Neoplasms
Central Nervous System Neoplasms
Urologic Neoplasms
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Neuroepithelioma
Glioma
Kidney Diseases
Nervous System Neoplasms
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Astrocytoma
Genital Neoplasms, Female
Endocrine System Diseases
Testicular Neoplasms
Renal cancer
Temozolomide
Carcinoma
Neuroectodermal Tumors
Sarcoma
Testicular cancer
Neoplasms, Glandular and Epithelial
Choroid Plexus Neoplasms
Gonadal Disorders
Ewing's family of tumors
Ovarian Diseases
Kidney cancer
Ependymoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents

ClinicalTrials.gov processed this record on October 10, 2008




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