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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003694 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: cytarabine Drug: omacetaxine mepesuccinate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Newly Diagnosed Patients With BCR/ABL (+) Chronic Myelogenous Leukemia Treated With Combined Homoharringtonine (NSC# 141633) and Low-Dose Cytarabine |
| Estimated Enrollment: | 60 |
| Study Start Date: | December 1998 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Assess the hematologic and cytogenetic response rate of newly diagnosed patients with chronic myelogenous leukemia treated with homoharringtonine and low dose cytarabine. II. Assess the toxicity of this combination regimen in these patients.
OUTLINE: Patients receive cytarabine and homoharringtonine concurrently by continuous intravenous infusion for 7 days. Courses repeat every 28 days. Patients receive a minimum of 9 courses of therapy in the absence of disease progression and unacceptable toxicity. Patients who are major cytogenetic responders at 9 months may continue therapy or switch to interferon. Minor cytogenetic responders are switched to interferon, and nonresponders are removed from therapy and given the option to switch to interferon. Patients are followed every 6 months for 10 years.
PROJECTED ACCRUAL: This study will accrue up to 60 patients in 1.5 years.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven, newly diagnosed chronic myelogenous leukemia in chronic phase Must meet one or more of the following criteria: Cytogenetically determined Philadelphia chromosome (Ph+) BCR/ABL protein detectable by immunoblotting Polymerase chain reaction positive fusion transcripts for BCR/ABL BCR/ABL translocation present by fluorescence in situ hybridization Must be ineligible for early allogeneic bone marrow transplant Must be registered on companion protocols CALGB-9665 and CALGB-29801
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon therapy Chemotherapy: No more than 8 weeks of prior hydroxyurea therapy No prior homoharringtonine No prior busulfan or cytarabine for disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy except for nondisease related conditions No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: No concurrent palliative radiotherapy for splenomegaly Surgery: No concurrent surgical splenectomy except in emergency situation
Contacts and Locations
Show 50 Study Locations| Study Chair: | Richard M. Stone, MD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000066797, CLB-19804 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003694 History of Changes |
| Health Authority: | United States: Federal Government |
|
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Homoharringtonine Physiological Effects of Drugs Leukemia Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Cytarabine |
Neoplasms by Histologic Type Hematologic Diseases Growth Substances Myeloproliferative Disorders Leukemia, Myeloid Antiviral Agents Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Antineoplastic Agents, Phytogenic |
