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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.