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Anti-metabolites

tretinoin for Myelodysplastic Syndrome

Phase 1 & 2
Waitlist Available
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after each cycle
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of tretinoin when given together with decitabine in treating patients with myelodysplastic syndromes.

Eligible Conditions
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after each cycle
This trial's timeline: 3 weeks for screening, Varies for treatment, and after each cycle for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical remission rate (complete and partial remission) (Phase II)
Hematologic and nonhematologic toxicities as measured by NCI CTC v2.0 (Phase I)
Maximum tolerated dose of tretinoin when administered with decitabine as determined by NCI CTC v2.0 (Phase I)
+1 more
Secondary outcome measures
Change in bone marrow function as measured by frequency of transfusion, bleeding, and infection as well as changes in bone marrow morphology and cytogenetics
Correlation of clinical response, with gene expression, demethylation of specific genes, and flow cytometric indicators of differentiation and apoptosis
Demethylation of specific genes as measured by gene promoter methylation studies
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Decitabine and All-Trans Retonoic Acid (Tretinoin)Experimental Treatment7 Interventions
Decitabine and All-Trans Retonoic Acid (Tretinoin)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
decitabine
2007
Completed Phase 2
~860
tretinoin
2007
Completed Phase 3
~720
microarray analysis
2006
Completed Phase 3
~3600
DNA methylation analysis
2007
Completed Phase 3
~2210
cytogenetic analysis
2006
Completed Phase 3
~1900

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,079 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,827 Total Patients Enrolled
Raajit Rampal, MD, PhDStudy ChairMemorial SloanKettering Cancer Center
2 Previous Clinical Trials
37 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What skin conditions does tretinoin cream help to heal?

"Tretinoin, while most commonly used to treat refractory anemias, can also be taken as medication for various other conditions including keratinization disorders of the feet and severe cystic acne."

Answered by AI

Can people of legal age participate in this research?

"This trial allows anyone aged 18 or above to enroll, with the maximum age limit set at 120 years old."

Answered by AI

Are there any patients currently participating in this trial?

"The clinicaltrials.gov website reveals that this trial is no longer recruiting patients. The posting date was July 1, 2006 and the last edit was on May 9, 20212. There are, however, 1799 other trials which are still looking for participants."

Answered by AI

How can I get involved in this clinical trial?

"Myelodysplastic syndromes patients that meet the following requirements are encouraged to participate in this trial. To be eligible, participants must be between 18-120 years old and have responded to decitabine therapy if they have received it in the past (as per International Working Group Response Criteria). Other notable inclusion criteria include being ineligible for transplantation and having either untreated or treated intermediate-1 risk disease, Intermediate-2 risk disease, High-risk disease, or No treatment-related MDS."

Answered by AI

What is the projected or estimated enrollment for this research project?

"At the moment, this trial is not looking for new patients. However, it's worth noting that this study was last updated on May 9th, 2022 and initially posted 16 years ago on July 1st, 2006. If you're interested in other trials, there are currently 1671 studies actively recruiting patients with myelodysplastic syndromes and 128 trials for tretinoin admitting participants."

Answered by AI

Are there any precedent studies involving tretinoin?

"There are currently 128 ongoing trials for tretinoin, with 21 of them in Phase 3. The vast majority of these studies are taking place in Reggio Emilia and Foggia, though there are a total of 1,783 locations running trials for tretinoin."

Answered by AI
~3 spots leftby Apr 2025