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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-21204 | |||
| ILEX-CCCWFU-21204 | |||
| CCCWFU-BG04-519 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clofarabine | Drug | |||
| cytarabine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | ||
| Safety profile and tolerability |
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DISEASE CHARACTERISTICS:
Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)
Meets 1 of the following criteria:
No symptomatic CNS involvement
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 1 week since prior therapy and recovered
No other concurrent chemotherapy
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
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| Name | Affiliation | Role |
|---|---|---|
| Bayard L. Powell, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D000013 | Congenital Abnormalities |
| D015471 | Leukemia, Basophilic, Acute |
| D015472 | Leukemia, Eosinophilic, Acute |
| D004915 | Leukemia, Erythroblastic, Acute |
| D007947 | Leukemia, Megakaryoblastic, Acute |
| D007948 | Leukemia, Monocytic, Acute |
| D015479 | Leukemia, Myelomonocytic, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077866 | Clofarabine |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |