NCT00002598

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Interferon alfa may interfere with the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and interferon alfa in treating patients with chronic myelogenous 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 Jun 1994

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

June 1, 1994

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

10 years

First QC Date

November 1, 1999

Last Update Submit

June 24, 2013

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemiablastic phase chronic myelogenous leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negative

Interventions

recombinant interferon alfaBIOLOGICAL
sargramostimBIOLOGICAL
cyclophosphamideDRUG
cytarabineDRUG
etoposideDRUG
methotrexateDRUG
mitoxantrone hydrochlorideDRUG
bone marrow ablation with stem cell supportPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of chronic myelogenous leukemia in blast crisis * Bone marrow blasts at least 20% OR * Bone marrow blasts plus promyelocytes at least 50% * Ineligible for higher priority protocols PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2.0 mg/dL Renal: * Creatinine less than 2.0 mg/dL Cardiovascular: * LVEF greater than 50% by MUGA scan or echocardiogram Other: * HIV negative * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Prior therapy for blast crisis allowed

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaBlast CrisisLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

Interferon-alphasargramostimCyclophosphamideCytarabineEtoposideMethotrexateMitoxantroneRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular 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 CompoundsGlucosidesGlycosidesCarbohydratesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAnthraquinonesAnthronesAnthracenesQuinonesTherapeutics

Study Officials

  • Mark Adam Weiss, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

June 1, 1994

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(1)