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Trial record 54 of 57 for:    "Germ Cells Tumors" | "Carboplatin"

Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer

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ClinicalTrials.gov Identifier: NCT00053118
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : March 1, 2011
Sponsor:
Information provided by:
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 27, 2003
First Posted Date  ICMJE January 28, 2003
Last Update Posted Date March 1, 2011
Study Start Date  ICMJE March 2002
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00053118 on ClinicalTrials.gov Archive Site
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 Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer
Official Title  ICMJE High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
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: Phase I trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation in treating children who have central nervous system cancer.

Detailed Description

OBJECTIVES:

  • Determine the feasibility of administering an outpatient protocol comprising high-dose carboplatin with autologous stem cell support and etoposide in pediatric patients with primary central nervous system malignancies.
  • Determine the maximum tolerated dose of carboplatin when administered in this regimen in these patients.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is dose-escalation study of carboplatin.

Patients receive filgrastim (G-CSF) IV once daily for 6 days followed by a maximum of 5 apheresis sessions. If the target number of peripheral blood stem cells is not achieved, some patients receive G-CSF and undergo apheresis as above after a 2-week rest.

At least 3 days after completion of G-CSF, patients receive high-dose carboplatin IV over 1 hour on day 1, stem cell reinfusion on day 3, G-CSF subcutaneously on days 4-18 and 43-61, and oral etoposide 3 times daily on days 21-42. Treatment continues for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin 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 monthly for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Neuroblastoma
  • Retinoblastoma
Intervention  ICMJE
  • Biological: filgrastim
    IV
  • Drug: carboplatin
    IV
  • Drug: etoposide
    IV
  • Procedure: bone marrow ablation with stem cell support
    IV
  • Procedure: peripheral blood stem cell transplantation
    IV
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
Actual Enrollment  ICMJE
 (submitted: February¬†25,¬†2011)
1
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2004
Actual Primary Completion Date July 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary central nervous system malignancy
  • Recurrent, persistent, or progressive disease after at least 1 prior first-line treatment regimen

PATIENT CHARACTERISTICS:

Age

  • 18 and under at initial diagnosis

Performance status

  • ECOG 0-2

Life expectancy

  • At least 8 weeks

Hematopoietic

  • Absolute neutrophil count greater than 750/mm^3
  • WBC greater than 2,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • No underlying myelodysplasia, stem cell disorder, or other inherent hematologic synthetic defect

Hepatic

  • Liver function tests less than 2 times normal OR
  • Absence of active hepatitis by liver biopsy
  • Bilirubin less than 1.5 mg/dL

Renal

  • Glomerular filtration rate greater than 60 mL/min by radionucleotide assay

Cardiovascular

  • Ejection fraction at least 45%

Pulmonary

  • Clinically normal pulmonary function (patients 5 years of age and under)
  • FEV_1 and FVC at least 50% (patients over 5 years of age) OR
  • Arterial blood gas normal and DLCO greater than 50%

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No mucositis or mucosal infection
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 3 weeks since prior systemic cytotoxic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 6 months since prior radiotherapy to the pelvis or spine

Surgery

  • Not specified
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 NCT00053118
Other Study ID Numbers  ICMJE CDR0000269284
RPCI-DS-00-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barbara Bambach, MD, Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Barbara Jean Bambach, MD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date February 2011

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