Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplasti… (NCT00114257) | Clinical Trial Compass
CompletedPhase 1
Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders
United States36 participantsStarted 2005-05
Plain-language summary
This phase I trial is studying the side effects and best dose of decitabine and FR901228 in treating patients with relapsed or refractory leukemia, myelodysplastic syndromes or myeloproliferative disorders. Drugs used in chemotherapy, such as decitabine and FR901228, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving decitabine together with FR901228 may kill more cancer cells.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following hematologic malignancies:
* Acute myeloid leukemia
* Previously untreated patients \> 60 years of age who are not eligible for front-line therapy are eligible for this study
* Acute lymphoblastic leukemia
* Chronic myelogenous leukemia (CML)
* Documented hematologic resistance to imatinib mesylate OR no cytogenetic response after 12 months of prior treatment with imatinib mesylate
* Philadelphia chromosome-negative CML allowed provided disease is resistant to standard therapy (e.g., hydroxyurea) OR disease progressed (blasts \> 5% and platelet count \< 100,000/mm\^3) during standard therapy
* Myelodysplastic syndromes
* International Prognostic Scoring System risk category ≥ intermediate-1
* Patients who are not eligible for front-line therapy are eligible for this study
* Myeloproliferative disease
* Chronic lymphocytic leukemia
* Failed or progressed during ≥ 1 prior fludarabine-based therapy AND alemtuzmab
* Acute promyelocytic leukemia
* Progressed after prior treatment with standard chemotherapy, tretinoin, and arsenic trioxide
* Chronic myelomonocytic leukemia
* Resistant to standard therapy (e.g., hydroxyurea) OR disease progressed (blasts \> 5% and platelet count \< 100,000/mm\^3) during standard therapy
* Relapsed or refractory disease
* No known brain or meningeal disease
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance st…