Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Relapsed Acute Lymphocytic Leukemia

July 9, 2013 updated by: University of Nebraska

HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have relapsed acute lymphocytic leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the efficacy of autologous peripheral blood stem cell (PBSC) transplantation for marrow reconstitution after high-dose carmustine, cytarabine, etoposide, and cyclophosphamide in children with relapsed acute lymphocytic leukemia.
  • Determine the dose effect of autologous PBSC on engraftment in this patient population.

OUTLINE: Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours on days 1-5. When blood counts recover, autologous peripheral blood stem cells (PBSC) are harvested and selected for mononuclear cells, granulocyte-macrophage colony-forming units, and CD34+ cells.

Patients receive preparative regimen comprising carmustine IV on days -8 and -3, cytarabine IV every 12 hours and etoposide IV every 12 hours on days -7 to -4, and cyclophosphamide IV on days -2 and -1. PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) beginning after PBSC transplantation. Male patients undergo radiotherapy to the testes before transplantation. Patients with a history of CNS leukemia undergo craniospinal irradiation before transplantation.

Patients are followed at 100 days, 6 months, and 1 year.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 5 years.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

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
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3330
        • University of Nebraska Medical 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

1 year to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia

    • Pathologic evidence of relapse in marrow, CNS, or testes
    • In second or later complete remission

  • Ineligible for allogeneic transplantation:

    • No suitable allogeneic donor (sibling or family donor or unrelated donor with no more than 1 HLA-A or -B antigen mismatch and HLA-DR identical) OR
    • Ineligible for preparative regimen including total-body irradiation

  • Peripheral blood stem cell collection feasible:

    • Patient size generally at least 8 kg
    • Able to place central venous catheter
    • Patient cooperative

PATIENT CHARACTERISTICS:

Age:

  • 1 to 19

Performance status:

  • Not moribund

Life expectancy:

  • No severe limits from disease other than leukemia

Hepatic:

  • Bilirubin no greater than 3 times normal for age
  • AST and/or GGT no greater than 3 times normal for age
  • No evidence of hepatic synthetic dysfunction

Renal:

  • GFR at least 50% of normal based on Glofil study or 12-hour creatinine clearance

Cardiovascular:

  • Cardiac contractility normal on echocardiogram

Pulmonary:

  • FVC and FEV_1 with or without DLCO at least 50% predicted

Other:

  • No significant active infection
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

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

Collaborators and Investigators

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

Sponsor

University of Nebraska

Investigators

  • Study Chair: Bruce G. Gordon, MD, University of Nebraska

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, 1995

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 17, 2003

First Posted (Estimate)

September 18, 2003

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

September 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNMC-06695
  • CDR0000064114 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-V95-0639

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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