S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia
Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00006020
Collaborator
National Cancer Institute (NCI) (NIH)
35
107
48
0.3
0
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
OBJECTIVES:
-
Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78.
-
Determine the frequency and severity of toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6 months for 3.5 years.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18 months.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
35 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)
Study Start Date
:
Jul 1, 2000
Actual Primary Completion Date
:
Jun 1, 2004
Actual Study Completion Date
:
Jul 1, 2004
Outcome Measures
Primary Outcome Measures
- CR [After induction therapy is completed]
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MBCCOP - Gulf Coast | Mobile | Alabama | United States | 36688 |
| 2 | CCOP - Western Regional, Arizona | Phoenix | Arizona | United States | 85006-2726 |
| 3 | Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona | United States | 85012 |
| 4 | Veterans Affairs Medical Center - Tucson | Tucson | Arizona | United States | 85723 |
| 5 | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | United States | 85724 |
| 6 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 7 | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | United States | 72205 |
| 8 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
| 9 | Veterans Affairs Medical Center - Long Beach | Long Beach | California | United States | 90822 |
| 10 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90033-0804 |
| 11 | Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California | United States | 90073 |
| 12 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
| 13 | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | United States | 94553 |
| 14 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609-3305 |
| 15 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 16 | University of California Davis Cancer Center | Sacramento | California | United States | 95817 |
| 17 | UCSF Comprehensive Cancer Center | San Francisco | California | United States | 94143-0128 |
| 18 | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | United States | 95403 |
| 19 | Stanford University | Stanford | California | United States | 94305 |
| 20 | David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
| 21 | University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver | Colorado | United States | 80010 |
| 22 | Veterans Affairs Medical Center - Denver | Denver | Colorado | United States | 80220 |
| 23 | MBCCOP - Howard University Cancer Center | Washington | District of Columbia | United States | 20060 |
| 24 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
| 25 | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | United States | 30905-5650 |
| 26 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813-2424 |
| 27 | MBCCOP - Hawaii | Honolulu | Hawaii | United States | 96813 |
| 28 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859-5000 |
| 29 | MBCCOP - University of Illinois at Chicago | Chicago | Illinois | United States | 60612-7323 |
| 30 | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | United States | 60612 |
| 31 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
| 32 | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | United States | 60141 |
| 33 | Loyola University Medical Center | Maywood | Illinois | United States | 60153-5500 |
| 34 | Genesis Medical Center | Davenport | Iowa | United States | 52804 |
| 35 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7353 |
| 36 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
| 37 | Veterans Affairs Medical Center - Wichita | Wichita | Kansas | United States | 67218 |
| 38 | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | United States | 40502-2236 |
| 39 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0084 |
| 40 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 41 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
| 42 | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | United States | 71130-3932 |
| 43 | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | United States | 71130 |
| 44 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 45 | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | United States | 02130 |
| 46 | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | United States | 48105 |
| 47 | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
| 48 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0912 |
| 49 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
| 50 | Veterans Affairs Medical Center - Detroit | Detroit | Michigan | United States | 48201-1932 |
| 51 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 52 | CCOP - Grand Rapids | Grand Rapids | Michigan | United States | 49503 |
| 53 | CCOP - Beaumont | Royal Oak | Michigan | United States | 48073-6769 |
| 54 | Providence Hospital - Southfield | Southfield | Michigan | United States | 48075-9975 |
| 55 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
| 56 | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | United States | 39531-2410 |
| 57 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 58 | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | United States | 39216 |
| 59 | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | United States | 64128 |
| 60 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 61 | St. Louis University Health Sciences Center | Saint Louis | Missouri | United States | 63110 |
| 62 | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri | United States | 63141 |
| 63 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65807 |
| 64 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 65 | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | United States | 87108-5138 |
| 66 | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | United States | 87131 |
| 67 | Veterans Affairs Medical Center - Albany | Albany | New York | United States | 12208 |
| 68 | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | United States | 10032 |
| 69 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 70 | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | United States | 27104-4241 |
| 71 | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45220-2288 |
| 72 | Barrett Cancer Center | Cincinnati | Ohio | United States | 45267-0501 |
| 73 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195-9001 |
| 74 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
| 75 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
| 76 | CCOP - Dayton | Dayton | Ohio | United States | 45429 |
| 77 | CCOP - Toledo Community Hospital | Toledo | Ohio | United States | 43623-3456 |
| 78 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 79 | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
| 80 | Oregon Cancer Institute | Portland | Oregon | United States | 97201-3098 |
| 81 | Veterans Affairs Medical Center - Portland | Portland | Oregon | United States | 97207 |
| 82 | CCOP - Columbia River Oncology Program | Portland | Oregon | United States | 97225 |
| 83 | Veterans Affairs Medical Center - Charleston | Charleston | South Carolina | United States | 29401-5799 |
| 84 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 85 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
| 86 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 87 | University of Tennessee Cancer Institute | Memphis | Tennessee | United States | 38103 |
| 88 | Danville Radiation Therapy Center | Memphis | Tennessee | United States | 38104 |
| 89 | Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 90 | Veterans Affairs Medical Center - Amarillo | Amarillo | Texas | United States | 79106 |
| 91 | Veterans Affairs Medical Center - Dallas | Dallas | Texas | United States | 75216 |
| 92 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234-6200 |
| 93 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0565 |
| 94 | Veterans Affairs Medical Center - Houston | Houston | Texas | United States | 77030 |
| 95 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229-3900 |
| 96 | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | United States | 78229 |
| 97 | Veterans Affairs Medical Center - Temple | Temple | Texas | United States | 76504 |
| 98 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
| 99 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112-5550 |
| 100 | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | United States | 84148 |
| 101 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05401 |
| 102 | MBCCOP - Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
| 103 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
| 104 | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | United States | 98104 |
| 105 | Veterans Affairs Medical Center - Seattle | Seattle | Washington | United States | 98108 |
| 106 | CCOP - Northwest | Tacoma | Washington | United States | 98405-0986 |
| 107 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431-5000 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Steven E. Coutre, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00006020
Other Study ID Numbers:
- S0010
- S0010
- U10CA032102
First Posted:
Jan 27, 2003
Last Update Posted:
Mar 6, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Southwest Oncology Group
Additional relevant MeSH terms: