Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Azacitidine; Decitabine; Tretinoin

Criteria

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