NCT00008190

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 II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation and interleukin-2 in treating patients who have acute leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 1999

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 4, 2013

Status Verified

April 1, 2004

Enrollment Period

6.7 years

First QC Date

January 6, 2001

Last Update Submit

February 1, 2013

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionsecondary acute myeloid leukemia

Interventions

aldesleukinBIOLOGICAL
filgrastimBIOLOGICAL
busulfanDRUG
cyclophosphamideDRUG
etoposideDRUG
melphalanDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed acute leukemia * High-risk due to any of the following: * Cytogenetic abnormalities involving 5q, 7q, 8q, 11q23, or t(9;22) * WBC greater than 100,000/mm3 * Prior myelodysplastic syndrome * Complete remission (CR) lasting less than 12 months * No favorable cytogenetic parameters (e.g., t(15;17), inv16, or t(8;21)) * CR following standard anti-leukemic therapy confirmed by bone marrow evaluation * Second and third CR allowed * Ineligible for higher priority national or institutional study or allogeneic peripheral blood stem cell transplantation PATIENT CHARACTERISTICS: Age: * Any age Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin less than 1.5 times normal * SGOT or SGPT less than 1.5 times normal Renal: * Creatinine less than 1.5 times normal Cardiovascular: * LVEF at least 45% if receiving cyclophosphamide * Normal electrocardiogram OR * Approval by cardiologist Pulmonary: * DLCO less than 60% predicted OR * Approval by pulmonologist Other: * Not pregnant or nursing * No concurrent illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified 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)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Interventions

aldesleukinFilgrastimBusulfanCyclophosphamideEtoposideMelphalanPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Charles S. Hesdorffer, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

March 1, 1999

Primary Completion

November 1, 2005

Study Completion

May 1, 2008

Last Updated

February 4, 2013

Record last verified: 2004-04

Locations

US(1)