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Keep this study
Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
National Cancer Institute (NCI)
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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumor not amenable to curative therapy
* Lymphoma allowed
Progressive disease
Evaluable disease
No CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Hemoglobin at least 8 g/dL (may be achieved by transfusion)
Absolute neutrophil count at least 1,500/mm\^3
Platelet count at least 100,000/mm\^3
Hepatic:
Bilirubin no greater than 2 mg/dL (unless due to hemolysis or Gilbert's syndrome)
SGOT and SGPT less than 2 times upper limit of normal
Renal:
Creatinine no greater than 2.0 mg/dL
Other:
No active infection
HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception for 2 weeks before, during, and 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
At least 4 weeks since prior adjuvant chemotherapy for advanced or metastatic disease and recovered
Endocrine therapy:
Not specified
Radiotherapy:
At least 4 weeks since prior radiotherapy and recovered
Surgery:
Not specified
Clareo Health | Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment
