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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.
 
ClinicalTrials.gov Identifier: NCT00025558
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 28, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE October 11, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date March 28, 2011
Study Start Date  ICMJE October 2000
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer
Official Title  ICMJE 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
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.

Detailed Description

OBJECTIVES:

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Biological: filgrastim
  • Drug: carboplatin
  • Drug: temozolomide
  • Drug: thiotepa
  • Procedure: autologous bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Over 1 to under 50

Performance status:

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

Life expectancy:

  • More than 12 weeks

Hematopoietic:

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

Hepatic:

  • 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

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 2 weeks since prior biologic therapy or immunotherapy

Chemotherapy:

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

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

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

Surgery:

  • See Disease Characteristics
  • Recovered from prior major surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00025558
Other Study ID Numbers  ICMJE CDR0000068973
P30CA016087 ( U.S. NIH Grant/Contract )
NYU-0006H
NCI-G01-2022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Sharon L. Gardner, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP