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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

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: NCT00005952
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE July 5, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date June 20, 2013
Study Start Date  ICMJE August 2000
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2007)
  • Overall response at 12 months
  • Disease-free survival at 12 months
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2007)
  • Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months
  • Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months
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 Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors
Official Title  ICMJE A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Head and Neck Cancer
  • Kidney Cancer
  • Neuroblastoma
  • Ovarian Cancer
  • Sarcoma
  • Testicular Germ Cell Tumor
Intervention  ICMJE
  • Biological: filgrastim
  • Drug: temozolomide
  • 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
Estimated Enrollment  ICMJE
 (submitted: February 8, 2007)
30
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00005952
Other Study ID Numbers  ICMJE 1735
DUMC-1735-04-9R5
DUMC-1735-02-9R3
DUMC-1735-01-9R2
DUMC-1833-99-10
NCI-G00-1796
CDR0000067932 ( Other Identifier: NCI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Henry S. Friedman, MD Duke Cancer Institute
PRS Account Duke University
Verification Date February 2013

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