NCT00002945

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. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells. PURPOSE: Phase III trial to study the effectiveness of high-dose combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have acute myeloid leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3 leukemia

Timeline
Completed

Started Dec 1996

Longer than P75 for phase_3 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1996

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 16, 2003

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

4.7 years

First QC Date

November 1, 1999

Last Update Submit

April 12, 2012

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemiaadult acute monoblastic leukemia and acute monocytic leukemia (M5)adult acute erythroid leukemia (M6)adult acute myeloblastic leukemia without maturation (M1)adult acute myeloblastic leukemia with maturation (M2)adult acute myelomonocytic leukemia (M4)adult acute megakaryoblastic leukemia (M7)secondary acute myeloid leukemiaadult acute minimally differentiated myeloid leukemia (M0)

Outcome Measures

Primary Outcomes (1)

  • To determine the efficacy of 4-6 h and 18-24 h, 20% ALA applications on superficial and nodular epidermally-derived lesions using ca633 nm laser irradiation.

    To determine the efficacy of 4-6 h and 18-24 h, 20% ALA applications on superficial and nodular epidermally-derived lesions using ca633 nm laser irradiation.

    24 hours

Interventions

aldesleukinBIOLOGICAL

IV

filgrastimBIOLOGICAL

IV

cyclophosphamideDRUG

IV

cytarabineDRUG

IV

etoposideDRUG

IV

idarubicinDRUG

IV

melphalanDRUG

IV

peripheral blood stem cell transplantationPROCEDURE

IV

radiation therapyRADIATION

delivered to the cancer cells

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven de novo or secondary acute myeloid leukemia with a classification of M0-M2 or M4-M7 * No classification of M3 * No promyelocytic leukemia * Prior medical conditions allowed: * Myelodysplastic syndromes * Aplastic anemia * Paroxysmal nocturnal hemoglobinuria * Myeloproliferative disorders except Philadelphia chromosome positive chronic myelogenous leukemia PATIENT CHARACTERISTICS: Age: * Over 25 Performance status: * Not specified Life expectancy: * At least 4 weeks Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2 times normal * SGOT no greater than 2 times normal * Alkaline phosphatase no greater than 2 times normal Renal: * Creatinine no greater than 1.5 times normal Cardiovascular: * Ejection fraction at least 45% * No severe cardiovascular disease including myocardial infarction within past 6 months, uncontrolled symptomatic congestive heart failure, angina pectoris, or multifocal cardiac arrhythmias Other: * No uncontrolled diabetes mellitus * No other active malignancy * No hypersensitivity to E. coli derived drug preparations PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for acute leukemia except hydroxyurea * Prior chemotherapy allowed for other malignancy or other medical condition Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy allowed for other malignancy or other medical condition 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)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Monocytic, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Megakaryoblastic, Acute

Interventions

aldesleukinFilgrastimCyclophosphamideCytarabineEtoposideIdarubicinMelphalanPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesDaunorubicinAnthracyclinesNaphthacenesAminoglycosidesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Meir Wetzler, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 16, 2003

Study Start

December 1, 1996

Primary Completion

August 1, 2001

Study Completion

August 1, 2011

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations

US(1)