S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

NCT ID: NCT00337168

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2013-01-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving cytarabine together with clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.

Detailed Description

Primary objective:

• Determine whether the complete remission rate in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) is sufficiently high after treatment with cytarabine and clofarabine to warrant further investigation.

Secondary objectives:

• Estimate the frequency and severity of toxicities associated with this dosing schedule of cytarabine and clofarabine.
• Investigate, preliminarily, the prognostic effects of cytogenetic features on response to treatment in these patients.

Other objectives (if funding allows):

• Investigate, preliminarily, the prognostic effects of laboratory correlates (expression of nucleoside transporters, expression of other pertinent genes by tissue microarray) and FISH features on response to treatment in these patients

OUTLINE: This is an open-label, multicenter study.

• Induction therapy (1 or 2 courses): Patients receive induction therapy comprising clofarabine IV over 1 hour followed 4 hours later by cytarabine IV over 2 hours on days 1-5 (course 1). Patients who achieve a response (5-25% blasts in the bone marrow with a ≥ 50% reduction in blasts from initial bone marrow aspirate) receive 1 more course of induction therapy beginning no later than day 45. Patients who achieve complete remission (< 5% blasts in the bone marrow) after 1 or 2 courses of induction therapy may proceed to consolidation therapy.
• Consolidation therapy (1 course): Beginning within 60 days after the first day of the last induction therapy, patients may receive consolidation therapy comprising clofarabine IV over 1 hour followed 4 hours later by cytarabine IV over 2 hours on days 1-4.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

clofarabine

Intervention Type: DRUG

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

cytarabine

Intervention Type: DRUG

Induction: 1g/m2/d; IV over 2 hrs; days 1-5 Re-induction (if necessary): 1g/m2/d; IV over 2 hrs; days 1-5 Consolidation: 1g/m2/d; IV over 2 hrs; days 1-4

Interventions

clofarabine

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

Intervention Type: DRUG

cytarabine

Induction: 1g/m2/d; IV over 2 hrs; days 1-5 Re-induction (if necessary): 1g/m2/d; IV over 2 hrs; days 1-5 Consolidation: 1g/m2/d; IV over 2 hrs; days 1-4

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anjali Advani, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Jerry Radich, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Providence Cancer Center

Anchorage, Alaska, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, United States

Stanford Cancer Center

Stanford, California, United States

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Northside Hospital Cancer Center

Atlanta, Georgia, United States

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

CCOP - Atlanta Regional

Atlanta, Georgia, United States

WellStar Cobb Hospital

Austell, Georgia, United States

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, United States

Southern Regional Medical Center

Riverdale, Georgia, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Southwest Medical Center

Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, United States

Associates in Womens Health, PA - North Review

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, United States

CCOP - Wichita

Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, United States

Wesley Medical Center

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, United States

Tulane Cancer Center Office of Clinical Research

Alexandria, Louisiana, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services

Billings, Montana, United States

Billings Clinic - Downtown

Billings, Montana, United States

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

St. James Healthcare Cancer Care

Butte, Montana, United States

Frontier Cancer Center

Great Falls, Montana, United States

Great Falls Clinic - Main Facility

Great Falls, Montana, United States

St. Peter's Hospital

Helena, Montana, United States

Glacier Oncology, PLLC

Kalispell, Montana, United States

Kalispell Medical Oncology at KRMC

Kalispell, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Grandview Hospital

Dayton, Ohio, United States

Good Samaritan Hospital

Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, United States

Samaritan North Cancer Care Center

Dayton, Ohio, United States

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, United States

CCOP - Dayton

Dayton, Ohio, United States

Blanchard Valley Medical Associates

Findlay, Ohio, United States

Middletown Regional Hospital

Franklin, Ohio, United States

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, United States

Charles F. Kettering Memorial Hospital

Kettering, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, United States

Clinton Memorial Hospital

Wilmington, Ohio, United States

Cleveland Clinic - Wooster

Wooster, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, United States

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Baylor University Medical Center - Houston

Houston, Texas, United States

Ben Taub General Hospital

Houston, Texas, United States

Methodist Hospital

Houston, Texas, United States

St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital

Houston, Texas, United States

Veterans Affairs Medical Center - Houston

Houston, Texas, United States

CCOP - Scott and White Hospital

Temple, Texas, United States

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

St. Joseph Cancer Center

Bellingham, Washington, United States

Olympic Hematology and Oncology

Bremerton, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Minor and James Medical, PLLC

Seattle, Washington, United States

Group Health Central Hospital

Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Polyclinic First Hill

Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, United States

Countries

United States

Other Identifiers

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SWOG-S0530

Identifier Type: OTHER

Identifier Source: secondary_id

S0530

Identifier Type: -

Identifier Source: org_study_id