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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00295841

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

119.2

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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 I trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: clofarabine Drug: cytarabine	Phase 1

Detailed Description

OBJECTIVES:

Determine the response rate in adult patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by clofarabine.
Document the safety profile and tolerability of this regimen in these patients.
Phase I: Patients receive high-dose cytarabine IV over 3 hours followed by clofarabine IV over 2 hours on days 1-5. Treatment repeats for up to 4 courses (1-2 induction courses, 2-3 post-remission courses) in the absence of disease progression or unacceptable toxicity.

A cohort of 3-6 patients receives the starting dose of clofarabine. If 1 of 6 patients experiences dose-limiting toxicity (DLT), a subsequent cohort of patients receives clofarabine at the next higher dose. If ≥ 2 of 6 patients experience DLT, the dose of cytarabine is reduced and subsequent cohorts of patients receive cytarabine at reduced doses and clofarabine as per the dose-escalation scheme above.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia

Study Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Jan 7, 2015

Actual Study Completion Date :

Jan 7, 2015

Outcome Measures

Primary Outcome Measures

Response rate []
Safety profile and tolerability []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)
No M3 AML
Meets 1 of the following criteria:
In first relapse
In second relapse after a second complete remission (CR) that lasted ≥ 3 months
Refractory to initial induction therapy
No symptomatic CNS involvement

PATIENT CHARACTERISTICS:

ECOG performance status ≤ 2
Creatinine < 2 mg/dL
Bilirubin ≤ 2 mg/dL
AST and ALT ≤ 4 times upper limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 weeks after completing study treatment
Ejection fraction ≥ 45% by echocardiogram
No active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant
No psychiatric disorders that would interfere with giving consent, study participation, or follow-up procedures
No other severe concurrent disease that would preclude study treatment

PRIOR CONCURRENT THERAPY:

At least 1 week since prior therapy and recovered
No other concurrent chemotherapy
Hydroxyurea to control WBC count before starting study treatment allowed
No concurrent corticosteroids unless used for diseases other than leukemia
No concurrent palliative radiotherapy
No concurrent growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) in patients with AML