Status:
COMPLETED
Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine the hematologic and nonhematologic toxicities of decitabine in combination with tretinoin in patients with myelodysplastic syndromes. (Phase I) * Determine the maximu...
Eligibility Criteria
Inclusion
- 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 allowed only in the setting of febrile neutropenia according to established guidelines for use
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00382200
Start Date
July 1 2006
End Date
January 5 2023
Last Update
May 20 2024
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065