Lymphoma Clinical Trial
Official title:
A Phase I Dose Escalation to Maximally Tolerated Dose Trial of 5-Azacytidine (5 AC, NSC 102816) in Combination With Sodium Phenylbutyrate (PB, NSC 657802) in Patients With Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine plus
phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not
responded to previous treatment.
OBJECTIVES:
- Evaluate the safety and toxicity of azacitidine plus phenylbutyrate in patients with
refractory solid tumors.
- Determine the maximum tolerated dose of this treatment regimen where maximal gene
reexpression occurs in these patients.
- Evaluate the pharmacokinetics of these drugs in these patients.
- Determine the minimally effective dose of azacitidine in combination with phenylbutyrate
that elicits a biological or clinical response in these patients.
OUTLINE: This is a dose escalation study.
Patients receive azacitidine subcutaneously for 14-21 days and sodium phenylbutyrate IV
continuously for 1-7 days. Treatment repeats every 35 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses and durations of treatment with azacitidine
and phenylbutyrate until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: Approximately 3-50 patients will be accrued for this study within 12-18
months.
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