S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute lymphoblastic leukemia, L1 adult acute lymphoblastic leukemia, L2 adult acute lymphoblastic leukemia, B-cell adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Prior morphologic diagnosis of acute lymphoblastic leukemia (ALL) No M0, mixed lineage, or L3 (Burkitt's) ALL Refractory to a standard induction regimen OR relapsed after successful prior induction therapy Standard induction regimen is defined as any program of treatment that includes vincristine and prednisone or high-dose cytarabine/mitoxantrone Any number of inductions or remissions allowed Must have evidence of ALL in bone marrow or peripheral blood Immunophenotyping of the blood or bone marrow lymphoblasts must be performed to determine lineage (B cell, T cell, or mixed B/T cell) No extramedullary only disease in the absence of bone marrow or blood involvement Co-expression of myeloid antigens (CD13 and CD33) allowed Patients with Philadelphia chromosome-positive (Ph+) ALL or bcr/abl-positive ALL who were previously eligible for imatinib mesylate treatment must have received imatinib mesylate either alone or in combination with chemotherapy for ALL and must have either failed treatment or been unable to tolerate treatment No CNS involvement as determined by lumbar puncture (for previous CNS history or clinical signs or symptoms of CNS) or by clinical exam (if no previous history or signs/symptoms) Must be registered on SWOG-S9910 and SWOG-9007 PATIENT CHARACTERISTICS: Zubrod performance status 0-2 Creatinine ≤ 1.5 times upper limit of normal (ULN) AST or ALT ≤ 1.5 times ULN Bilirubin ≤ 1.5 times ULN No psychiatric disorders that would interfere with study compliance No uncontrolled systemic fungal, bacterial, viral, or other infection No other severe concurrent disease No other serious or poorly controlled medical condition that would preclude study participation No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that would preclude study participation HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No pre-existing motor or sensory neuropathy ≥ grade 2 No other prior malignancies, except for the following: Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer in complete remission Any other prior cancer for which the patient has been disease free for ≥ 5 years PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior therapy No prior clofarabine More than 2 weeks since prior chemotherapy, major surgery, or other investigational agents More than 6 weeks since prior monoclonal antibodies Prior allogeneic or autologous bone marrow transplant allowed provided the following criteria are met: More than 90 days since transplant No acute graft-versus-host disease (GVHD) ≥ grade 2 OR moderate or severe limited chronic GVHD OR extensive chronic GVHD of any severity Prior maintenance therapy with steroids, vincristine, and/or anti-metabolite agents, such as, but not limited to, mercaptopurine, thioguanine, or methotrexate allowed Concurrent hydroxyurea allowed
Sites / Locations
- Providence Cancer Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Stanford Cancer Center
- M.D. Anderson Cancer Center at Orlando
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas, PA - Winfield
- Tulane Cancer Center Office of Clinical Research
- University of Michigan Comprehensive Cancer Center
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Frontier Cancer Center
- Great Falls Clinic - Main Facility
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Cleveland Clinic Taussig Cancer Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Community Oncology Group at Cleveland Clinic Cancer Center
- Charles F. Kettering Memorial Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Clinton Memorial Hospital
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Hollings Cancer Center at Medical University of South Carolina
- Baylor University Medical Center - Houston
- Ben Taub General Hospital
- Methodist Hospital
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
- Veterans Affairs Medical Center - Houston
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute at University of Utah
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Wenatchee Valley Medical Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Induc, ReInduc, Consol, clofarabine, cytarabine
Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4