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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
sargramostim
carmustine
cyclophosphamide
cytarabine
etoposide
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
University of Nebraska
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute lymphoblastic leukemia

Eligibility Criteria

1 Year - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 9, 2013
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT00002638
Brief Title
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Relapsed Acute Lymphocytic Leukemia
Official Title
HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA
Study Type
Interventional

2. Study Status

Record Verification Date
September 2002
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Nebraska

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent childhood acute lymphoblastic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce G. Gordon, MD
Organizational Affiliation
University of Nebraska
Official's Role
Study Chair
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
Country
United States

12. IPD Sharing Statement

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

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