Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes (NCT00382200) | Clinical Trial Compass
CompletedPhase 1/2
Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes
United States54 participantsStarted 2006-07
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of myelodysplastic cells, either by killing the cells or by stopping them from dividing. Tretinoin and decitabine may help myelodysplastic cells become more like normal cells, and to grow and spread more slowly. Giving decitabine together with tretinoin may be an effective treatment for myelodysplastic syndromes.
PURPOSE: This phase I/II trial is studying the side effects and best dose of tretinoin when given together with decitabine in treating patients with myelodysplastic syndromes.
Who can participate
Age range
18 Years – 120 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 myelodysplastic syndromes (MDS)
* International Prognostic scoring system (IPSS) score ≥ 0.5, including the following:
* Untreated or treated intermediate-1 risk disease
* Intermediate-2 risk disease
* High-risk disease
* No treatment-related MDS
* Ineligible for transplantation
* No decitabine-refractory disease defined as disease progression after discontinuation of therapy
* If previously treated with decitabine, must have responded to therapy (hematologic improvement or better per International Working Group Response Criteria)
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Bilirubin ≤ 2.5 mg/dL
* AST and ALT ≤ 2 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other medical condition that, in the opinion of the treating physician, would preclude patient compliance or put patient at excessive risk of treatment-related toxicity
* No other malignancy that would likely require systemic chemotherapy within 4 months after starting study treatment
* No allergy to parabens, vitamin A, or retinoids
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior azacytidine allowed
* More than 4 weeks since prior cytotoxic chemotherapy or radiotherapy
* More than 4 weeks since prior experimental therapy
* Concurrent myeloid growth factors al…
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.
What they're measuring
1
Number of Participants Evaluated for Hematologic and Nonhematologic Toxicities as Measured by NCI CTC v2.0
Timeframe: Up to 1 year
2
Maximum Tolerated Dose of Tretinoin When Administered With Decitabine as Determined by NCI CTC v2.0 (Phase II)
Timeframe: Up to 1 year
3
Overall Response Rate
Timeframe: Up to 1 year
4
Rate of Hematologic Improvement as Measured by Responding Cell Lines (Erythroid, Platelet, and Neutrophil Response) (Phase II)