Cytarabine and Clofarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00295841
First received: February 23, 2006
Last updated: July 31, 2012
Last verified: April 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: clofarabine Drug: cytarabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Comprehensive Cancer Center of Wake Forest University:
Primary Outcome Measures:
- Response rate [ Designated as safety issue: No ]
- Safety profile and tolerability [ Designated as safety issue: Yes ]
| Enrollment: | 53 |
| Study Start Date: | February 2005 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295841
Locations
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
| Study Chair: | Bayard L. Powell, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00295841 History of Changes |
| Other Study ID Numbers: | CDR0000466307, CCCWFU-21204, ILEX-CCCWFU-21204, CCCWFU-BG04-519 |
| Study First Received: | February 23, 2006 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute basophilic leukemia adult acute eosinophilic leukemia adult erythroleukemia (M6a) |
adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine |
Clofarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013