DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia

Intervention: hydroxyurea (Drug); Homoharringtonine (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Dan DeAngelo, MD, Study Chair, Affiliation: Dana-Farber Cancer Institute

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if homoharringtonine is more effective than hydroxyurea for chronic myelogenous leukemia that has not responded to interferon alfa. PURPOSE: Randomized phase III trial to compare the effectiveness of homoharringtonine with that of hydroxyurea in treating patients who have chronic myelogenous leukemia that has not responded to interferon alfa.

Clinical Details

Official title: A Phase III Study of Interferon-Refractory Patients With BCR/ABL(+) Chronic Myelogenous Leukemia (CML) Treated With Homoharringtonine (NSC #141633) vs. Hydroxyurea

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall survival

Detailed description: OBJECTIVES: I. Compare the overall survival of interferon alfa refractory chronic myelogenous leukemia patients treated with homoharringtonine to those treated with hydroxyurea. II. Compare the time to progression of these patients treated with these two drugs. III. Estimate the complete and major cytogenetic response and describe the serial cytogenetics of these patients treated with these two drugs. OUTLINE: This is a randomized study. Patients are randomized to receive one of two treatments. Arm I: Induction: Patients receive homoharringtonine IV continuously over 24 hours daily for 14 days. Induction continues every 28 days for a maximum of 6 courses or until hematopoietic recovery. Maintenance: Patients receive homoharringtonine IV continuously over 24 hours daily for 5 days. Treatment repeats every 28 days. Arm II: Induction: Patients receive oral hydroxyurea daily for 28 days until acceptable blood counts are achieved. Maintenance: Patients receive oral hydroxyurea daily every 28 days to maintain acceptable blood counts. Treatment in both arms continues for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for a maximum of 10 years. PROJECTED ACCRUAL: A total of 480 patients (240 per arm) will be accrued for this study within 4 years.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

1. Documentation of Disease: 1. 1 Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible. Clonal cytogenetic evolution alone does not exclude patients. See Appendix I for definitions of accelerated and blastic phases of CML. 1. 2 Patients in whom a Philadelphia chromosome [t(9;22)] is not detectable by cytogenetic studies are eligible if they meet one of the following criteria:

- BCR/ABL protein detectable by immunoblotting

- BCR/ABL rearrangement detectable by Southern blot analysis

- Polymerase chain reaction (PCR) positive fusion transcripts for BCR/ABL

- BCR/ABL translocation present by fluorescence in situ hybridization (FISH).

2. Prior Treatment: 2. 1 No previous therapy with homoharringtonine (HHT) 2. 2 No more than six months cumulative (<180 days) of prior hydroxyurea (HU) therapy. However, patients may not have received more than 60 days of HU treatment after failing interferon. Patients with previous intolerance or failure to respond to HU are not eligible. 2. 3 Patients must have failed an adequate trial (5M units/m2/day) of alpha-Interferon (IFN) or IFN/ara-C to be eligible, as defined below (any ONE of the following):

- Failure to achieve a complete hematologic response after 6 months of IFN

therapy.

- Failure to achieve any cytogenetic response (i. e., still 100% Ph+) after 12

months of IFN therapy.

- Intolerable adverse effects of IFN therapy after at least one month of IFN

treatment. Significant documented toxicity of ≥ grade 3 (using NCI Common Toxicity Criteria guidelines) due to IFN is required.

- Loss of a prior hematologic remission or cytogenetic response to IFN.

- A two-fold increase in WBC count when compared to WBC count when IFN therapy was

initiated. 3. Age ≥ 16 years 4. Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible. 5. Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.

Locations and Contacts

Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama 35233, United States

MBCCOP - University of South Alabama, Mobile, Alabama 36688, United States

CCOP - Greater Phoenix, Phoenix, Arizona 85006-2726, United States

Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix, Arizona 85012, United States

Arizona Cancer Center, Tucson, Arizona 85724, United States

Veterans Affairs Medical Center - Tucson, Tucson, Arizona 85723, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas 72205, United States

University of California San Diego Cancer Center, La Jolla, California 92093-0658, United States

Veterans Affairs Medical Center - Long Beach, Long Beach, California 90822, United States

Beckman Research Institute, City of Hope, Los Angeles, California 91010, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

USC/Norris Comprehensive Cancer Center, Los Angeles, California 90033-0800, United States

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California 94553, United States

CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States

Chao Family Comprehensive Cancer Center, Orange, California 92868, United States

University of California Davis Medical Center, Sacramento, California 95817, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California 94115-0128, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California 94121, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

David Grant Medical Center, Travis Air Force Base, California 94535, United States

University of Colorado Cancer Center, Denver, Colorado 80262, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware 19899, United States

Lombardi Cancer Center, Georgetown University, Washington, District of Columbia 20007, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States

Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia 30905-5650, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637, United States

University of Illinois at Chicago Health Sciences Center, Chicago, Illinois 60612, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois 60612, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois 60141, United States

Loyola University Medical Center, Maywood, Illinois 60153, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky 40536-0084, United States

Veterans Affairs Medical Center - Lexington, Lexington, Kentucky 40511-1093, United States

MBCCOP - LSU Medical Center, New Orleans, Louisiana 70112, United States

Tulane University School of Medicine, New Orleans, Louisiana 70112, United States

Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana 70112, United States

Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana 71130-3932, United States

Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana 71130, United States

Veterans Affairs Medical Center - Togus, Togus, Maine 04330, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland 21201, United States

Boston Medical Center, Boston, Massachusetts 02118, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts 02130, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01655, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0752, United States

Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan 48105, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Veterans Affairs Medical Center - Detroit, Detroit, Michigan 48201-1932, United States

CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan 49503, United States

Providence Hospital - Southfield, Southfield, Michigan 48075-9975, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417, United States

Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi 39531-2410, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

Veterans Affairs Medical Center - Jackson, Jackson, Mississippi 39216, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi 39534-2576, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri 65201, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri 64128, United States

Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri 63141, United States

St. Louis University Health Sciences Center, Saint Louis, Missouri 63110-0250, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire 03756, United States

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States

Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico 87108-5138, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Veterans Affairs Medical Center - Buffalo, Buffalo, New York 14215, United States

CCOP - North Shore University Hospital, Manhasset, New York 11030, United States

North Shore University Hospital, Manhasset, New York 11030, United States

Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

Mount Sinai Medical Center, NY, New York, New York 10029, United States

New York Presbyterian Hospital - Cornell Campus, New York, New York 10021, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13217, United States

State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York 13210, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina 27705, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157-1082, United States

Barrett Cancer Center, The University Hospital, Cincinnati, Ohio 45219, United States

Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio 45220-2288, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States

CCOP - Dayton, Kettering, Ohio 45429, United States

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 73104, United States

Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma 73104, United States

CCOP - Columbia River Program, Portland, Oregon 97213, United States

Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon 97201-3098, United States

Veterans Affairs Medical Center - Portland, Portland, Oregon 97207, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Medical University of South Carolina, Charleston, South Carolina 29425-0721, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

University of Tennessee, Memphis Cancer Center, Memphis, Tennessee 38103, United States

Veterans Affairs Medical Center - Memphis, Memphis, Tennessee 38104, United States

Simmons Cancer Center - Dallas, Dallas, Texas 75235-9154, United States

Brooke Army Medical Center, Fort Sam Houston, Texas 78234, United States

University of Texas Medical Branch, Galveston, Texas 77555-0209, United States

Texas Tech University Health Science Center, Lubbock, Texas 79423, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States

Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas 78284, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Veterans Affairs Medical Center - Temple, Temple, Texas 76504, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84132, United States

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah 84148, United States

CCOP - Southwestern Vermont Regional Cancer Center, Bennington, Vermont 05201, United States

Vermont Cancer Center, Burlington, Vermont 05401-3498, United States

Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont 05009, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Veterans Affairs Medical Center - Richmond, Richmond, Virginia 23249, United States

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States

Swedish Cancer Institute, Seattle, Washington 98104, United States

Veterans Affairs Medical Center - Seattle, Seattle, Washington 98108, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

Additional Information

Starting date: January 2000
Last updated: June 23, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017