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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Cancer and Leukemia Group B |
| 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: Homoharringtonine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 |
| Enrollment: | 45 |
| Study Start Date: | December 1998 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Homoharringtonine + Cytarabine
Combination of homoharringtonine and cytarabine infusion for patients with BCR/ABL+ CML
|
Drug: cytarabine
7.5 mg/sq m/day for 7 days continuous IV infusion; repeat cycle every 28 days for 9 months; pt can opt to con't if responding
Other Name: ara-C
Drug: Homoharringtonine
2.5 mg/sq m/day continuous IV infusion for 7 days; repeat cycle for 9 months; pt can opt to con't if responding
Other Name: Cephalotaxine
|
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
| Responsible Party: | Monica M Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00003694 History of Changes |
| Other Study ID Numbers: | CDR0000066797, U10CA031946, CLB-19804 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Cytarabine Homoharringtonine Harringtonines Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
