Tanespimycin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, or Myelodysplastic Syndromes

Completed · Phase 1

Conditions studied: Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, 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 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 Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts in Transformation, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes

In brief

This phase I trial is studying the side effects and best dose of tanespimycin when given with cytarabine in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndromes. Drugs used in chemotherapy, such as tanespimycin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Tanespimycin may also help cytarabine kill more cancer cells by making cancer cells more sensitive to the drug. Giving tanespimycin together with cytarabine may kill more cancer cells.

Key facts

Study ID

NCT00098423

Run by

National Cancer Institute (NCI)

People needed

42

Starts

2004-11-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1 of the following:
• Acute myeloid leukemia, except acute promyelocytic leukemia (M3 disease), meeting 1 of the following criteria:
• Failed to achieve complete remission (CR) after initial induction therapy regimen*
• First relapse within 1 year of initial CR
• Failed re-induction therapy at first or second relapse
• Second or third relapse after completing ≤ 3 different induction therapy regimens
• Antecedent hematologic disorder (myelodysplastic syndromes [MDS], chronic myeloproliferative disease, or chronic myelomonocytic leukemia [CMML])
• Received prior chemotherapy for a non-hematologic malignancy
• High-risk cytogenetic abnormalities (abnormalities of chromosome 5, 7, 8, or 11 OR ≥ 3 karyotypic abnormalities)
• Acute lymphoblastic leukemia, meeting 1 of the following criteria:
• Failed to achieve CR after initial induction therapy regimen
• First relapse within 1 year of initial CR
• Failed re-induction therapy at first or second relapse
• Second or third relapse after completing ≤ 3 different induction therapy regimens
• Chronic myelogenous leukemia, meeting the following criteria:
• Accelerated OR blast phase (> 10% increase in the blast percentage in bone marrow)
• Failed prior imatinib mesylate
• No more than 1 prior chemotherapy regimen in addition to imatinib mesylate
• CMML, meeting the following criteria:
• More than 10% increase in blast percentage AND organ infiltration OR impending marrow failure as evidenced by cytopenia
• No t(5;12) by cytogenetics (unless failed prior trial of imatinib mesylate)
• High-grade MDS, defined as > 10% blasts on marrow cellularity (refractory anemia with excess blasts in transformation) OR International Prognostic Scoring System MDS prognostic score > 1.5
• Not a candidate for allogenic bone marrow transplantation* from a related sibling donor (i.e., HLA-identical sibling)
• No known standard or potentially curative therapy exists or is capable of extending life expectancy
• No clinical symptoms suggesting CNS leukemia

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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