Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment

Completed · Phase 1

Conditions studied: Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID: NCT00005639
Run by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
People needed: 34
Starts: 2000-03-01
Expected to finish: 2005-07-01
Last updated by the study team: 2019-01-11

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify 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

Where it is running

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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