Leukemia Clinical Trial
Official title:
A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have
recurrent or refractory acute lymphocytic leukemia.
Status | Completed |
Enrollment | 35 |
Est. completion date | July 2004 |
Est. primary completion date | June 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of acute lymphocytic leukemia (ALL) - FAB class L1-L2 - Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in peripheral blood, bone marrow, or in at least 1 extramedullary disease site) - Coexpression of myeloid antigens CD13 or CD33 allowed - Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed - CD3 and myeloperoxidase marker negative - Meeting 1 of the following criteria for recurrent/refractory disease: - Refractory to standard induction regimen including at least vincristine and prednisone - Recurrence after response after prior induction therapy - Recurrence and failure on subsequent treatment - No CNS involvement - Must be registered on SWOG-S9910 and SWOG-9007 PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - Zubrod 0-3 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT or SGPT no greater than 3 times ULN Renal: - Creatinine no greater than 2 times ULN Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No grade 2 or greater neuropathy - No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Veterans Affairs Medical Center - Albany | Albany | New York |
United States | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico |
United States | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | Veterans Affairs Medical Center - Amarillo | Amarillo | Texas |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan |
United States | CCOP - Atlanta Regional | Atlanta | Georgia |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | Veterans Affairs Medical Center - Charleston | Charleston | South Carolina |
United States | MBCCOP - University of Illinois at Chicago | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois |
United States | Barrett Cancer Center | Cincinnati | Ohio |
United States | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Veterans Affairs Medical Center - Dallas | Dallas | Texas |
United States | Genesis Medical Center | Davenport | Iowa |
United States | CCOP - Dayton | Dayton | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado |
United States | Veterans Affairs Medical Center - Denver | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Veterans Affairs Medical Center - Detroit | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | MBCCOP - Hawaii | Honolulu | Hawaii |
United States | Tripler Army Medical Center | Honolulu | Hawaii |
United States | Veterans Affairs Medical Center - Houston | Houston | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi |
United States | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri |
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
United States | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas |
United States | Veterans Affairs Medical Center - Long Beach | Long Beach | California |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California |
United States | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Danville Radiation Therapy Center | Memphis | Tennessee |
United States | University of Tennessee Cancer Institute | Memphis | Tennessee |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma |
United States | Chao Family Comprehensive Cancer Center | Orange | California |
United States | CCOP - Western Regional, Arizona | Phoenix | Arizona |
United States | Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Oregon Cancer Institute | Portland | Oregon |
United States | Veterans Affairs Medical Center - Portland | Portland | Oregon |
United States | MBCCOP - Massey Cancer Center | Richmond | Virginia |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri |
United States | St. Louis University Health Sciences Center | Saint Louis | Missouri |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | CCOP - Virginia Mason Research Center | Seattle | Washington |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington |
United States | Veterans Affairs Medical Center - Seattle | Seattle | Washington |
United States | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana |
United States | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana |
United States | Providence Hospital - Southfield | Southfield | Michigan |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Stanford University | Stanford | California |
United States | CCOP - Northwest | Tacoma | Washington |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | Veterans Affairs Medical Center - Temple | Temple | Texas |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona |
United States | Veterans Affairs Medical Center - Tucson | Tucson | Arizona |
United States | MBCCOP - Howard University Cancer Center | Washington | District of Columbia |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Veterans Affairs Medical Center - Wichita | Wichita | Kansas |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CR | After induction therapy is completed | No |
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