Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Antirheumatic Agents

Etoposide

Cytarabine

Cyclophosphamide

Lenograstim

Etoposide phosphate

Clofarabine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Antimetabolites

Antiviral Agents

Adjuvants, Immunologic

All patients receive the same treatment regimen consisting of clofarabine, etoposide, cyclophosphamide, cytarabine, and filgrastim. Up to 4 courses of therapy may be given.

40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5.

100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5.

440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5.

Administered in Courses 1 and 2 only. 5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is \> 1000 x 2 days.

Filgrastim

Given intrathecally on day 1 at the dose defined by age below:

30 mg for patients age 1-1.99 50 mg for patients age 2-2.99 70 mg for patients \>3 years of age

Paul Gaynon, MD

Nobuko Hijiya, MD

Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®).

Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study to find out the highest doses of these drugs that can be safely given to children with relapsed or refractory leukemia. This study is a phase II study which will use the drugs to study how well these drugs work against AML. This study will also examine the safety of this drug combination.

T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

T2007-002 A Phase II Study of Clofarabine With Etoposide and Cyclophosphamide in Relapsed/Refractory AML (IND 104,650)

Disease response assessed after chemotherapy from bone marrow aspirates/biopsies and complete blood count.

Genzyme, a Sanofi Company

Therapeutic Advances in Childhood Leukemia Consortium

The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions.

Patients were evaluated regularly by the treating physician.

Enrolled Patients

Baseline measures were collected for all enrolled patients.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Trial was terminated early due to loss of funding and concern that accrual goals could not be met. All six patients enrolled were deemed evaluable toxicity. No analysis was conducted on the study outcome variables.

Peggy Romano, BA, CCRP

All patient that completed at least 1 treatment course.

Patients that completed at least 1 treatment course of study drug.

Achievement of Complete Remission (CR) at Reinduction

Death

All patients receive the same treatment regimen consisting of clofarabine, etoposide, cyclophosphamide, cytarabine, and filgrastim.

clofarabine: 40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5.

etoposide: 100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5.

cyclophosphamide: 440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5.

filgrastim: 5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is \> 1000 x 2 days.

cytarabine: Given intrathecally on day 1 at the dose defined by age below. 30 mg for patients age 1-1.99 50 mg for patients age 2-2.99 70 mg for patients \>3 years of age

Spots Global Cancer Trial Database for T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

Trial Identification

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Study Description

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