Leukemia Clinical Trial
Official title:
A Phase I, Dose-Finding Trial of Sodium Phenylbutrate (NSC 657802) in Combination With All Trans-retinoic Acid (ATRA, NSC 122758) in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal
white blood cells.
PURPOSE: Phase I trial to study the effectiveness of combining phenylbutyrate and tretinoin
in treating patients who have hematologic cancer.
OBJECTIVES:
- Determine the safety and toxicity of phenylbutyrate and tretinoin in patients with
myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.
- Determine the pharmacokinetic interaction of this regimen in these patients.
- Determine any potential therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose escalation study of tretinoin.
Patients receive phenylbutyrate IV continuously on days 1-7 of weeks 1, 5, 7, 9, 11, 13, 15,
17, and 19. Patients also receive oral tretinoin three times daily on days 1-7 of weeks 3, 5,
7, 9, 11, 13, 15, 17, and 19. Treatment continues in the absence of disease progression or
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tretinoin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6
patients experience dose limiting toxicities.
An additional cohort of 6 patients is accrued at the MTD. These patients receive
phenylbutyrate IV continuously on days 1-3 of weeks 1 and 3-18. These patients also receive
oral tretinoin three times daily on days 1-3 of weeks 2-18. Treatment continues in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 18 months.
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