NCT00002574

Brief Summary

Phase II trial to study the effectiveness of homoharringtonine and interferon alfa in treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P75+ for phase_2 leukemia

Geographic Reach
1 country

2 active sites

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

September 1, 1994

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

August 10, 2004

Completed
Last Updated

February 5, 2013

Status Verified

October 1, 2001

Enrollment Period

6.8 years

First QC Date

November 1, 1999

Last Update Submit

February 4, 2013

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemiachronic phase chronic myelogenous leukemia

Study Arms (1)

Arm I

EXPERIMENTAL

Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.

Biological: recombinant interferon alfaDrug: omacetaxine mepesuccinate

Interventions

recombinant interferon alfaBIOLOGICAL
Arm I
omacetaxine mepesuccinateDRUG
Arm I

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Chronic myelogenous leukemia (CML) in chronic phase * Clonal evolution (i.e., the presence of clones other than the Ph chromosome) allowed Ph chromosome variants or complex Ph chromosome translocations are not considered disease acceleration * Ineligible for known therapy of higher efficacy or priority * Allogeneic bone marrow transplantation should be considered priority therapy for CML patients with a matched related donor * No blastic phase CML (30% or more blasts in peripheral blood or bone marrow) * No accelerated phase CML, defined as any of the following: 15% or more peripheral or marrow blasts or 30% or more blasts and promyelocytes 20% or more peripheral or marrow basophils * Thrombocytopenia (platelets less than 100,000) unrelated to therapy * Documented extramedullary disease outside of liver or spleen PATIENT CHARACTERISTICS: * Age: 15 and over * Performance status: Zubrod 0-2 * Life expectancy: Sufficient to fully evaluate the effects of 2 courses of therapy * Bilirubin no greater than 2.0 mg/dL * SGOT less than 300 * Creatinine less than 2.0 mg/dL OR creatinine clearance at least 60 mL/min * No severe heart disease (class III/IV) * No pregnant or nursing women * Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: * No prior interferon alpha * At least 2 weeks since antileukemic therapy, with recovery required * Patients who received hydroxyurea within the past 2 weeks and have WBC greater than 50,000 may enter protocol after discussion with the primary investigator

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

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-Phase

Interventions

Interferon-alphaHomoharringtonine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsHarringtoninesAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 4 or More Rings

Study Officials

  • Susan M. O'Brien, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 10, 2004

Study Start

September 1, 1994

Primary Completion

June 1, 2001

Last Updated

February 5, 2013

Record last verified: 2001-10

Locations

US(2)