NCT00002638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Mar 1995

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1995

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

September 18, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

July 10, 2013

Status Verified

September 1, 2002

First QC Date

November 1, 1999

Last Update Submit

July 9, 2013

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemia

Interventions

filgrastimBIOLOGICAL
sargramostimBIOLOGICAL
carmustineDRUG
cyclophosphamideDRUG
cytarabineDRUG
etoposideDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age1 Year - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

FilgrastimsargramostimCarmustineCyclophosphamideCytarabineEtoposidePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Bruce G. Gordon, MD

    University of Nebraska

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 18, 2003

Study Start

March 1, 1995

Study Completion

March 1, 2005

Last Updated

July 10, 2013

Record last verified: 2002-09

Locations

US(1)