Completed

PHASE II STUDY OF SIMULTANEOUS HOMOHARRINGTONINE (NSC 141633) AND ALPHA INTERFERON (IFN-A) THERAPY IN CHRONIC MYELOGENOUS LEUKEMIA (CML)

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What is being tested

recombinant interferon alfa

+ omacetaxine mepesuccinate

BiologicalDrug
Who is being recruted

Bone Marrow Diseases+11

+ Chronic Disease

+ Hematologic Diseases

Over 15 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1994
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1994

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the efficacy of homoharringtonine administered simultaneously with interferon alpha in achieving complete cytogenetic response in patients with chronic myelogenous leukemia in chronic phase. OUTLINE: Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.

NCT00002574
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

87 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveDisease AttributesLeukemiaLeukemia, Myeloid, Chronic-Phase

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Dana-Farber Cancer Institute

Boston, United StatesOpen Dana-Farber Cancer Institute in Google Maps

University of Texas - MD Anderson Cancer Center

Houston, United States
Completed2 Study Centers