Know Cancer

or
forgot password

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


Phase 2
15 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Susan M. O'Brien, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02233

NCT ID:

NCT00002574

Start Date:

September 1994

Completion Date:

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115