Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment
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|ClinicalTrials.gov Identifier: NCT00005639|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 16, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: azacitidine Drug: sodium phenylbutyrate||Phase 1|
- 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.
|Study Type :||Interventional (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|
|Study Start Date :||June 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005639
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Michael A. Carducci, MD||Sidney Kimmel Comprehensive Cancer Center|