Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: recombinant interferon alfa Drug: omacetaxine mepesuccinate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PHASE II STUDY OF SIMULTANEOUS HOMOHARRINGTONINE (NSC 141633) AND ALPHA INTERFERON (IFN-A) THERAPY IN CHRONIC MYELOGENOUS LEUKEMIA (CML) |
| Enrollment: | 87 |
| Study Start Date: | September 1994 |
| Primary Completion Date: | June 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.
|
Biological: recombinant interferon alfa Drug: omacetaxine mepesuccinate |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Susan M. O'Brien, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002574 History of Changes |
| Other Study ID Numbers: | NCI-2012-02233, MDA-DM-93151, NCI-T93-0191D, CDR0000063647 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Interferon-alpha Interferon Alfa-2a Interferons Homoharringtonine Harringtonines |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013