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

Sponsored by:	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 August 2007, this study is only recruiting patients for the Phase II portion of the study.

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

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

Drug Information available for: Cyclophosphamide Etoposide Etoposide phosphate Clofarabine

U.S. FDA Resources

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.

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 ]

Estimated Enrollment:	58
Study Start Date:	March 2006
Estimated Study Completion Date:	February 2010

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

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
Body weight > 10 kg
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 (FAB L3-ALL)
Previous treatment with clofarabine
Uncontrolled systemic fungal, bacterial or other infection
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; ≤ 4 months since HSCT
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

Contacts

Contact: Medical Information	800-745-4447	medinfo@genzyme.com
Contact: Medical Information	617-252-7832	medinfo@genzyme.com

Locations

United States, Alabama
Children's Hospital of Alabama	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Julia Adams 205-558-2984
Principal Investigator: Roger Berkow, M.D.
United States, California
Children's Hospital of Los Angeles	Recruiting
Los Angeles, California, United States, 90027
Contact: Armi Bui 323-361-7203
Principal Investigator: Paul Gaynon, M.D.
Rady Children's Hospital	Recruiting
San Diego, California, United States, 92123
Contact: Mehrzad Milburn 858-966-8155
Principal Investigator: Richard P. Kadota, M.D.
Children's Hospital of Orange County	Recruiting
Orange, California, United States, 92868
Contact: Laura Gates 714-516-4203
Principal Investigator: Violet Shen, MD
Stanford University Medical Center & Lucile Packard Children's Hospital	Recruiting
Palo Alto, California, United States, 94304
Contact: Nadeem Mukhtar 650-497-8815
Principal Investigator: Gary Dahl, M.D.
United States, Connecticut
Connecticut Children's Medical Center	Recruiting
Hartford, Connecticut, United States, 06106
Contact: Robin Arens 860-545-9614
Principal Investigator: Michael Isakoff, MD
United States, Illinois
Children's Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60614
Contact: Jennifer Dino 773-880-4956
Principal Investigator: Nobuko Hijiya, MD
United States, Indiana
St. Vincent Children's Hospital	Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Linda Cheatham 317-338-9825
Principal Investigator: Bassem Razzouk, MD
United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jane O'Brien 617-632-3549
Principal Investigator: Lewis Silverman, M.D.
United States, Michigan
Children's Hospital of Michigan	Recruiting
Detroit, Michigan, United States, 48201
Contact: Laura Strathdee 313-745-5520
Principal Investigator: Roland Chu, M.D.
United States, New York
New York School of Medicine	Recruiting
New York, New York, United States, 10016
Contact: Gina Im 212-263-9931
Principal Investigator: William Carroll, M.D.
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Elizabeth Dekosko 646-888-5723
Principal Investigator: Peter Steinherz, M.D.
United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Linda Holloway 901-595-3192
Principal Investigator: Sima Jeha, M.D.
United States, Texas
University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Eleanor Willis 713-795-8829
Principal Investigator: Michael Rytting, M.D.
Methodist Children's Hospital and Texas Transplant Institute	Recruiting
San Antonio, Texas, United States, 78229
Contact: Kathi Cobb 210-575-4224
Principal Investigator: Gerardo Quezada, M.D.
United States, Washington
Seattle Children's Hospital	Recruiting
Seattle, Washington, United States, 98105
Contact: Krishna Potluri 206-884-8141
Principal Investigator: Blythe Thomson, MD

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Rekha Abichandani, M.D.

Genzyme

More Information

Additional Information:

US FDA Approved Full Prescribing Information for Clolar® This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	CLO21800205
Study First Received:	April 18, 2006
Last Updated:	February 11, 2009
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

Study placed in the following topic categories:

Clofarabine
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immunologic Factors
Leukemia, Myeloid
Cyclophosphamide
Leukemia, Myeloid, Acute
Immunosuppressive Agents
Etoposide phosphate
Leukemia

Lymphatic Diseases
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Alkylating Agents
Etoposide
Lymphoma
Acute Lymphoblastic Leukemia

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 May 07, 2009