A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias. - Full Text View

Sponsor:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00315705

Purpose

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

The purpose of this study is to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe and effective in children with relapsed and refractory acute lymphoblastic leukemia or acute myelogenous leukemia.

As of November 2009, this study is active, but not recruiting.

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia Relapsed Leukemia	Drug: clofarabine (IV formulation), etoposide, cyclophosphamide	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cyclophosphamide Etoposide Etoposide phosphate Clofarabine

U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:

Maximum tolerated dose [ Time Frame: Phase I portion of study ] [ Designated as safety issue: No ]
Dose limiting toxicity [ Time Frame: Phase I portion of study ] [ Designated as safety issue: No ]
Recommended Phase II dose [ Time Frame: Phase I portion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall remission rate (partial, time to remission) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Event free survival (EFS) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
4-month EFS [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Pharmacokinetics/Correlative Studies [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	March 2006
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: clofarabine (IV formulation), etoposide, cyclophosphamide Clofarabine 20‑40 mg/m²/day 2hr IV infusion daily x 5; Etoposide 75‑100 mg/m²/day 2hr IV infusion daily x 5; Cyclophosphamide 340-440 mg/m²/day 30-60 min IV infusion daily x 5 RP2D (recommended Phase 2 doses) Clofarabine 40mg/m², Etoposide 100 mg/m², Cyclophosphamide 440 mg/m²

Eligibility

Ages Eligible for Study:	1 Year to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

NOTE: the following eligibility criteria was applicable to ALL and AML patients for the Phase I portion of this study; and is applicable to ALL patients only for the Phase II portion of the study.
ALL with > 25% blasts in bone marrow; AML with ≥ 5% blasts in bone marrow; ALL and AML patients may have extramedullary disease
KPS ≥ 50 for patients > 10 years old; LPS ≥ 50 for patients ≤ 10 years old
Prior therapy: AML: 1-2 prior induction regimens and ≤ 1 hematopoietic stem cell transplant (HSCT); ALL: 1-3 prior induction regimens
Adequate liver, renal, pancreatic, and cardiac function
Have received no prior HSCT

Exclusion Criteria:

NOTE: the following eligibility criteria was applicable to ALL and AML patients for the Phase I portion of this study; and is applicable to ALL patients only for the Phase II portion of the study.
Burkitt's leukemia
Previous treatment with clofarabine
Uncontrolled systemic fungal, bacterial or other infection and 48 hrs negative blood cultures required for patients with a history of fever within 3 days of enrollment
Active CNS involvement (i.e., should be CNS1 or CNS2)
Inadequate time since last therapy: ≤ 14 days since last cytotoxic chemotherapy; ≤ 7 days since last biologic therapy; ≤ 14 days since last monoclonal antibody therapy
Have received a HSCT
Pregnant or lactating
Have known hepatitis B or C infection or history of cirrhosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315705

Locations

United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Stanford University Medical Center & Lucile Packard Children's Hospital
Palo Alto, California, United States
Rady Children's Hospital
San Diego, California, United States
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States
United States, Indiana
St. Vincent Children's Hospital
Indianapolis, Indiana, United States
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States
United States, New York
New York School of Medicine
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Methodist Children's Hospital and Texas Transplant Institute
San Antonio, Texas, United States
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	CLO21800205
Study First Received:	April 18, 2006
Last Updated:	January 19, 2010
ClinicalTrials.gov Identifier:	NCT00315705 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

clofarabine
acute leukemia
ALL

AML
clolar
CLO218

Additional relevant MeSH terms:

Leukemia, Lymphoid
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Leukemia, Myeloid, Acute
Etoposide phosphate
Leukemia
Therapeutic Uses
Etoposide
Alkylating Agents
Clofarabine
Immunoproliferative Disorders

Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Leukemia, Myeloid
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 04, 2010