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

Sponsor:	University of Nebraska
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002638

Purpose

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.

Condition	Intervention	Phase
Leukemia	Biological: filgrastim Biological: sargramostim Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Cyclophosphamide Cytarabine hydrochloride Etoposide Granulocyte-macrophage colony-stimulating factor Etoposide phosphate Filgrastim Sargramostim Lenograstim Granulocyte colony-stimulating factor Cytarabine Carmustine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	30
Study Start Date:	March 1995

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.

Eligibility

Ages Eligible for Study:	1 Year to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002638

Locations

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

Sponsors and Collaborators

University of Nebraska

Investigators

Study Chair:

Bruce G. Gordon, MD

University of Nebraska

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00002638 History of Changes
Other Study ID Numbers:	CDR0000064114, UNMC-06695, NCI-V95-0639
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Carmustine
Cyclophosphamide
Cytarabine
Etoposide
Lenograstim
Antineoplastic Agents, Alkylating

Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012