Official Title: Phase II Study of 506U78 for Refractory or Relapsed T-Cell Acute Lymphoblastic
Leukemia or Lymphoblastic Lymphoma
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Histologically confirmed diagnosis of T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)
Leukemia or lymphoma cells should express at least two of the following cell surface antigens: CD1a, CD2, CD3
(surface or cytoplasmic), CD4, CD5, CD7, and CD8
Leukemia cells should be negative for myeloperoxidase or Sudan Black B
If the only T cell markers present are CD4 and CD7, the leukemic cells should be demonstrated to lack the myeloid
markers CD33 and/or CD13
Refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete
remission
No CNS leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy
--Prior/Concurrent Therapy--
Biologic therapy: No concurrent erythropoietin
Chemotherapy: See Disease Characteristics No other concurrent chemotherapy
Endocrine therapy: No concurrent dexamethasone or other steroidal antiemetics No concurrent hormone therapy, except
for non-disease-related conditions
Radiotherapy: See Disease Characteristics
Surgery: Not specified
--Patient Characteristics--
Age: 16 and over
Performance status: Not specified
Life expectancy: Not specified
Hematopoietic: Not specified
Hepatic: Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)
Renal: Creatinine clearance at least 50 mL/min (unless due to leukemia)
Neurologic: No neurologic toxicity of grade 3 or greater during prior treatment of ALL/LBL No preexisting neuropathy
of grade 2 or greater regardless of causality
Other: No history of seizure disorder Not pregnant or nursing Fertile patients must use effective contraception
Alabama MBCCOP - Gulf Coast, Mobile,
Alabama,
36688,
United States
Arizona Arizona Cancer Center, Tucson,
Arizona,
85724,
United States
CCOP - Greater Phoenix, Phoenix,
Arizona,
85006-2726,
United States
Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix,
Arizona,
85012,
United States
Veterans Affairs Medical Center - Tucson, Tucson,
Arizona,
85723,
United States
Arkansas 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
California Cancer Center and Beckman Research Institute, City of Hope, Duarte,
California,
91010-3000,
United States
CCOP - Bay Area Tumor Institute, Oakland,
California,
94609-3305,
United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa,
California,
95403,
United States
Chao Family Comprehensive Cancer Center, Orange,
California,
92868,
United States
David Grant Medical Center, Travis Air Force Base,
California,
94535,
United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,
California,
90095-1781,
United States
Stanford University, Stanford,
California,
94305,
United States
University of California Davis Medical Center, Sacramento,
California,
95817,
United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,
California,
90033-0804,
United States
Veterans Affairs Medical Center - Long Beach, Long Beach,
California,
90822,
United States
Veterans Affairs Medical Center - West Los Angeles, Los Angeles,
California,
90073,
United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez,
California,
94553,
United States
Colorado University of Colorado Cancer Center, Denver,
Colorado,
80010,
United States
Veterans Affairs Medical Center - Denver, Denver,
Colorado,
80220,
United States
Georgia CCOP - Atlanta Regional, Atlanta,
Georgia,
30342-1701,
United States
Dwight David Eisenhower Army Medical Center, Fort Gordon,
Georgia,
30905-5650,
United States
Hawaii Cancer Research Center of Hawaii, Honolulu,
Hawaii,
96813,
United States
Illinois CCOP - Central Illinois, Decatur,
Illinois,
62526,
United States
Loyola University Medical Center, Maywood,
Illinois,
60153,
United States
MBCCOP - University of Illinois at Chicago, Chicago,
Illinois,
60612-7323,
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines,
Illinois,
60141,
United States
Kansas CCOP - Wichita, Wichita,
Kansas,
67214-3882,
United States
University of Kansas Medical Center, Kansas City,
Kansas,
66160-7357,
United States
Veterans Affairs Medical Center - Wichita, Wichita,
Kansas,
67218,
United States
Kentucky 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
Louisiana Louisiana State University Health Sciences Center - Shreveport, Shreveport,
Louisiana,
71130-3932,
United States
MBCCOP - LSU Health Sciences Center, New Orleans,
Louisiana,
70112,
United States
Tulane University School of Medicine, New Orleans,
Louisiana,
70112,
United States
Veterans Affairs Medical Center - Shreveport, Shreveport,
Louisiana,
71130,
United States
Massachusetts Boston Medical Center, Boston,
Massachusetts,
02118,
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain,
Massachusetts,
02130,
United States
Michigan Barbara Ann Karmanos Cancer Institute, Detroit,
Michigan,
48201-1379,
United States
CCOP - Ann Arbor Regional, Ann Arbor,
Michigan,
48106,
United States
CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids,
Michigan,
49503,
United States
Henry Ford Hospital, Detroit,
Michigan,
48202,
United States
Providence Hospital - Southfield, Southfield,
Michigan,
48075-9975,
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
Veterans Affairs Medical Center - Detroit, Detroit,
Michigan,
48201-1932,
United States
Minnesota CCOP - Duluth, Duluth,
Minnesota,
55805,
United States
Mississippi Keesler Medical Center - Keesler AFB, Keesler AFB,
Mississippi,
39534-2576,
United States
University of Mississippi Medical Center, Jackson,
Mississippi,
39216-4505,
United States
Veterans Affairs Medical Center - Biloxi, Biloxi,
Mississippi,
39531-2410,
United States
Veterans Affairs Medical Center - Jackson, Jackson,
Mississippi,
39216,
United States
Missouri CCOP - Cancer Research for the Ozarks, Springfield,
Missouri,
65807,
United States
CCOP - Kansas City, Kansas City,
Missouri,
64131,
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
Veterans Affairs Medical Center - Kansas City, Kansas City,
Missouri,
64128,
United States
Montana CCOP - Montana Cancer Consortium, Billings,
Montana,
59101,
United States
New Mexico MBCCOP - University of New Mexico HSC, Albuquerque,
New Mexico,
87131,
United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque,
New Mexico,
87108-5138,
United States
New York Herbert Irving Comprehensive Cancer Center, New York,
New York,
10032,
United States
North Carolina CCOP - Southeast Cancer Control Consortium, Winston Salem,
North Carolina,
27104-4241,
United States
Ohio Barrett Cancer Center, The University Hospital, Cincinnati,
Ohio,
45219,
United States
CCOP - Columbus, Columbus,
Ohio,
43206,
United States
CCOP - Dayton, Kettering,
Ohio,
45429,
United States
CCOP - Toledo Community Hospital Oncology Program, Toledo,
Ohio,
43623-3456,
United States
Cleveland Clinic Taussig Cancer Center, Cleveland,
Ohio,
44195,
United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati,
Ohio,
45220-2288,
United States
Veterans Affairs Medical Center - Dayton, Dayton,
Ohio,
45428,
United States
Oklahoma University of Oklahoma Health Sciences Center, Oklahoma City,
Oklahoma,
73190,
United States
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City,
Oklahoma,
73104,
United States
Oregon CCOP - Columbia River Program, Portland,
Oregon,
97213,
United States
Oregon Cancer Center, Portland,
Oregon,
97201-3098,
United States
Veterans Affairs Medical Center - Portland, Portland,
Oregon,
97207,
United States
South Carolina CCOP - Greenville, Greenville,
South Carolina,
29615,
United States
CCOP - Upstate Carolina, Spartanburg,
South Carolina,
29303,
United States
Texas Brooke Army Medical Center, Fort Sam Houston,
Texas,
78234,
United States
CCOP - Scott and White Hospital, Temple,
Texas,
76508,
United States
Simmons Cancer Center - Dallas, Dallas,
Texas,
75235-9154,
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
University of Texas Medical Branch, Galveston,
Texas,
77555-0209,
United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,
Texas,
78284,
United States
Veterans Affairs Medical Center - Temple, Temple,
Texas,
76504,
United States
Utah Huntsman Cancer Institute, Salt Lake City,
Utah,
84112,
United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,
Utah,
84148,
United States
Washington CCOP - Northwest, Tacoma,
Washington,
98405-0986,
United States
CCOP - Virginia Mason Research Center, Seattle,
Washington,
98101,
United States
Madigan Army Medical Center, Tacoma,
Washington,
98431-5000,
United States
Swedish Cancer Institute, Seattle,
Washington,
98104,
United States
Veterans Affairs Medical Center - Seattle, Seattle,
Washington,
98108,
United States