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NCT Number: NCT00002574

Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant interferon alfa

Biological

Omacetaxine mepesuccinate

Drug

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

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

Important dates

Study start
1994
Primary completion
2001
First posted
Aug 10, 2004
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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