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

February 25, 2011 updated by: Roswell Park Cancer Institute

High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Study Chair: Barbara Jean Bambach, MD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

January 27, 2003

First Submitted That Met QC Criteria

January 27, 2003

First Posted (Estimate)

January 28, 2003

Study Record Updates

Last Update Posted (Estimate)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 25, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000269284
  • RPCI-DS-00-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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