Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors Tha… (NCT00005639) | Clinical Trial Compass
CompletedPhase 1
Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment
United States34 participantsStarted 2000-03
Plain-language summary
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.
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion criteria:
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
What they're measuring
1
Minimal Effective Dose (MED) of Azacitidine with Phenylbutyrate
Timeframe: up to 6 months
Trial details
NCT IDNCT00005639
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins