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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025558
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 28, 2011
National Cancer Institute (NCI)
Information provided by:
NYU Langone Health

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining temozolomide, thiotepa, and carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have brain cancer.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: filgrastim Drug: carboplatin Drug: temozolomide Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of temozolomide in combination with thiotepa and carboplatin followed by autologous peripheral blood stem cell or bone marrow transplantation in patients with recurrent high-grade brain tumors with minimal residual disease or newly-diagnosed malignant glioma with minimal residual disease following irradiation.

OUTLINE: This is a dose-escalation study of temozolomide.

Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily for 3 consecutive days. After the third dose of G-CSF, patients undergo leukapheresis to collect peripheral blood stem cells (PBSC). Patients who do not have adequate PBSC may undergo bone marrow harvest.

Patients then receive oral temozolomide every 12 hours on days -10 to -6 and thiotepa IV over 3 hours and carboplatin IV over 4 hours on days -5 to -3.

PBSC or bone marrow are reinfused on day 0. Beginning on day 1, patients receive G-CSF SC or IV until blood counts recover.

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 preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at day 42, at 3 months, every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Dose Escalation of Temozolomide in Combination With Thiotepa and Carboplatin With Autologous Stem Cell Rescue in Patients With Malignant Brain Tumors With Minimal Residual Disease
Study Start Date : October 2000
Actual Primary Completion Date : May 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of one of the following malignant brain tumors:

    • Anaplastic astrocytoma
    • Glioblastoma multiforme
    • Anaplastic oligodendroglioma
    • Medulloblastoma
    • High-grade ependymoma
    • Germ cell tumors
    • Pineoblastoma
    • Other primitive neuroectodermal tumors
  • Recurrent disease or resistant to conventional therapy (e.g., surgery, radiotherapy, or standard chemotherapy)

    • No prior myeloablative doses of thiotepa OR
  • Newly diagnosed malignant glioma with minimal residual disease after prior radiotherapy

    • Minimal residual disease is defined as tumor with maximum diameter of less than 1.5 cm by MRI and no corticosteroid dependency



  • Over 1 to under 50

Performance status:

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

Life expectancy:

  • More than 12 weeks


  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 10 g/dL (transfusion allowed)


  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT less than 2.5 times ULN
  • Alkaline phosphatase less than 2.5 times ULN


  • Creatinine less than 1.5 times ULN
  • Creatinine clearance at least 70 mL/min
  • BUN less than 1.5 times ULN


  • Ejection fraction greater than 50% OR
  • Shortening fraction greater than 27%
  • No evidence of myocardial ischemia on EKG if over 40 years of age


  • HIV negative
  • No AIDS-related illness
  • No frequent vomiting or medical condition that would preclude oral medication (e.g., partial bowel obstruction)
  • No other malignancy within the past 2 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 2 weeks since prior biologic therapy or immunotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • See Disease Characteristics


  • See Disease Characteristics
  • At least 6 weeks since prior radiotherapy and recovered
  • At least 6 weeks since prior brachytherapy or radiosurgery


  • See Disease Characteristics
  • Recovered from prior major surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00025558

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United States, New York
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, Ohio
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
NYU Langone Health
National Cancer Institute (NCI)
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Study Chair: Sharon L. Gardner, MD NYU Langone Health
Layout table for additonal information Identifier: NCT00025558    
Other Study ID Numbers: CDR0000068973
P30CA016087 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: March 2011
Keywords provided by NYU Langone Health:
childhood central nervous system germ cell tumor
recurrent adult brain tumor
adult medulloblastoma
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult central nervous system germ cell tumor
adult pineoblastoma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood medulloblastoma
recurrent childhood ependymoma
adult giant cell glioblastoma
adult gliosarcoma
adult anaplastic ependymoma
adult supratentorial primitive neuroectodermal tumor (PNET)
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents